Pharmalot, Pharmalittle: Drug companies hiring hemophilia patients, Merck settles lawsuit

first_img @Pharmalot Tags drug pricesMerck Merck agreed to pay $830 million to resolve a long-running, class-action lawsuit that accused the drug maker of hiding the risks of its Vioxx painkiller. The drug maker withdrew the pill in 2004 after a clinical trial indicated an increased risk of heart attack and stroke. Three years later, Merck agreed to pay $4.85 billion to settle lawsuits brought by patients. The company expects that insurance will cover about $150 million of the latest settlement.The Italian Medicines Agency reached a deal with drug makers that sets payment for cancer treatments based on how well patients respond, Bloomberg News reports. And in situations in which a medicine does not help patients, a drug maker is obligated to offer a refund. More than 90 such contracts were signed in 2014, compare with fewer than 20 in 2012.advertisement And so, another working week is about to come to a close. And this was a particularly long one for us, since we were traipsing around the annual JP Morgan Healthcare Conference the past few days. What better way to recuperate, though, than to daydream about weekend plans? Our agenda is quite modest. We look forward to spending time with Mrs. Pharmalot and our shortest of short people, and take a few naps. And you? The long weekend may be a good time to catch up with friends, tidy around the castle and simply enjoy life. Whatever you do, have a grand time. But be safe. See you soon …One person is brain dead and five others are seriously ill after participating in a clinical trial for an unnamed drug company at a clinic in France, The Guardian reports. The French health ministry said the six patients were in good health until taking the pill. Another report said the drug was a painkiller containing cannabinoids, an active ingredient found in cannabis plants.More companies that make hemophilia drugs, as well as specialty pharmacies that dispense the treatments, are hiring patients and their relatives in hopes of gaining access and boosting sales, The New York Times writes. “There are a lot more patients that work in industry now than ever before,” Michelle Rice, vice president for public policy and stakeholder relations at the National Hemophilia Foundation, told the paper.advertisement By Ed Silverman Jan. 15, 2016 Reprints The US Patent and Trademark Office denied petitions filed by Amgen to review two patents on Humira, which could set back its efforts to sell a biosimilar version of the best-selling AbbVie drug, Reuters says.Five years after a partner at the Reed Smith law firm stepped in front of a train, his widow moved closer to trial accusing GlaxoSmithKline of hiding the suicide risks of its Paxil antidepressant, The American Lawyer says.More than 62,000 bottles of Azithromycin tablets manufactured by Wockhardt, one of India’s largest generic drug makers, are being recalled by PD-Rx Pharmaceuticals in the US, The Economic Times reports.A federal appeals court upheld a lower-court ruling that found Eli Lilly did not discriminate against three former female employees, The Indiana Lawyer writes.Philidor Rx Services, the specialty pharmacy that Valeant Pharmaceuticals had used to boost its sales, is letting go of 264 employees in the Phoenix area, The Phoenix Business Journal says.Giving healthy gay men HIV drugs before they are exposed to the virus could prevent many cases and significantly reduce incidence of the disease, Pharma Times tells us. About the Author Reprintscenter_img [email protected] Ed Silverman Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Alex Hogan/STAT PharmalotPharmalot, Pharmalittle: Drug companies hiring hemophilia patients, Merck settles lawsuit last_img read more

CDC tells pregnant women: Don’t go to the Summer Olympics in Brazil

first_imgPoliticsCDC tells pregnant women: Don’t go to the Summer Olympics in Brazil The CDC said women who are trying to become pregnant and are considering going to Brazil for the events in August and September should talk to their doctors about their risk of infection and should take all necessary steps to avoid being bitten by mosquitoes. Are you at risk of contracting Zika virus?Volume 90%Press shift question mark to access a list of keyboard shortcutsKeyboard ShortcutsEnabledDisabledPlay/PauseSPACEIncrease Volume↑Decrease Volume↓Seek Forward→Seek Backward←Captions On/OffcFullscreen/Exit FullscreenfMute/UnmutemSeek %0-9 facebook twitter Email Linkhttps://www.statnews.com/2016/02/26/cdc-pregnant-zika-olympics/?jwsource=clCopied EmbedCopiedLive00:0001:3301:33  Are you at risk for contracting Zika virus? Your level of risk depends in part on your living conditions. Alex Hogan/STAT To limit the extent of further Zika transmission, some observers are even calling on the International Olympic Committee to postpone the Games.Zika virus is normally transmitted to people through the bite of an infected Aedes mosquito. But evidence is mounting that transmission through sex — from an infected male to his partner — is not only possible, but may happen more frequently than previously believed.The CDC this week reported it was exploring 14 suspected cases of sexual transmission in women whose sex partners had become infected during travel abroad.Two of those cases have since been discounted. But two have been confirmed, four others are considered probable cases, and six more are still under investigation.The CDC has urged pregnant women to avoid travel to nearly three dozen countries and territories in Latin America and the Caribbean because of concerns they will contract the Zika virus.Zika infection is also believed to increase the risk of developing Guillain-Barré syndrome, a progressive paralysis from which most people eventually recover. @HelenBranswell Pregnant women should avoid this summer’s Olympic and Paralympic Games in Rio de Janeiro, the US Centers for Disease Control and Prevention said Friday.The public health agency has been urging pregnant women for several weeks to avoid traveling to places where the Zika virus is spreading. But up until now, it has side-stepped the question of the Brazil Olympiad.In fact, three weeks ago the director of the CDC’s division of global migration and quarantine told STAT the question of the Summer Olympics was definitely on the CDC’s radar, but the agency felt it could hold off for a bit longer.advertisement By Helen Branswell Feb. 26, 2016 Reprints Related: The agency warned that pregnant women who have a male partner going to Brazil for the Olympics or the Paralympics are at risk of becoming infected through sex and should either use condoms properly for all sex or abstain for the rest of their pregnancies. Nine pregnant women in the US were infected with Zika, CDC says center_img Citing concerns over Zika virus, the US Centers for Disease Control and Prevention advised pregnant women to avoid traveling to the 2016 Summer Olympics in Rio de Janeiro. Craig F. Walker/Boston Globe About the Author Reprints Helen Branswell Senior Writer, Infectious Disease Helen covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. Dr. Martin Cetron said at the time the suspected link between Zika infection in pregnancy and microcephaly, a serious birth defect, would likely become clearer before the CDC had to make a decision about the Olympics.It has made one now. Pregnant women should consider not attending the Games, advice posted on the CDC’s website Friday said. Pregnant women who must go should speak with their doctor first and do everything they can to avoid being bitten by mosquitoes during their time in Brazil.advertisement Tags CDCinfectious diseaseOlympicspolicypregnancypublic healthvirologyZika Viruslast_img read more

In coordinated nurses strike across the US, Boston may be next

first_img About 4,800 nurses at five Minneapolis-area hospitals, all operated by Allina Health, began a strike Sunday. Jerry Holt /Star Tribune via AP About the Author Reprints Priyanka Dayal McCluskey — Boston Globe Boston nurses may strike in coordination with union members in other states By Priyanka Dayal McCluskey — Boston Globe June 24, 2016 Reprints Tags policy PoliticsIn coordinated nurses strike across the US, Boston may be next last_img read more

The curious case of the $9,500 skin gel

first_imgPharmalotThe curious case of the $9,500 skin gel By Ed Silverman Sept. 23, 2016 Reprints There was another big price hike earlier this year. And this month, Novum boosted prices again. Alcortin A and Aloquin each now list for $9,561 per tube. And the wholesale price for its Novacort gel rose to $7,142 from $4,186 for a small tube, according to Truven Health Analytics. Even in an age when prescription drugs are increasingly expensive, a $9,500 tube of gel to combat scaly skin can gain notice — especially when the price spikes 128 percent overnight.That’s what happened earlier this month when a little-known company called Novum Pharma suddenly hiked wholesale prices for all three of its dermatology products by whopping amounts.We were curious. So we started poking around to learn more about Novum Pharma.advertisement What did we learn? It appears to be a furtive vehicle for scooping up older medicines from other companies and then boosting prices significantly. And its chief executive did the very same thing at a previous job, at Horizon Pharma.Let’s start at the beginning: Novum bought three gels to treat skin conditions in March of 2015. Two months after it acquired them, it jacked up the prices tenfold. That’s right, tenfold. For instance, the wholesale price for Alcortin A, a gel used to treat dermatitis and eczema, went from $226 to $2,995.advertisement Related: Alex Hogan/STAT @Pharmalot Please enter a valid email address. About the Author Reprints Privacy Policy Tags dermatologydrug pricespharmaceutical industrycenter_img Pharma’s secret weapon to keep drug prices high Ed Silverman How the generic EpiPen could actually be more profitable for Mylan Related: Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. [email protected] Though its statement blamed middlemen for passing on extra costs to patients, Novum then went on to claim that patients don’t actually pay much for its products. The company said people with commercial insurance “only pay $0” for Novum gels, “even when their insurance doesn’t cover them.” It added that “cash-paying patients never have to pay more than $35.”We asked for more detailed explanations, but never received a reply.But getting even this much of an answer proved challenging.If you visit the Novum web site, there’s not much to see beyond information about its three products. This is a privately held company. There’s no information whatsoever about the management. There are two phone numbers listed: One is for obtaining coupons to reduce the cost of the gels. The other is not answered by a real person, though you can leave a message. Not very helpful.Since the Novum website says it is a limited liability corporation based in Indiana, we searched a state government site for the filing history. This indicated the company was organized in Delaware in early 2015, and the name of the manager who signed the form was Gavin Toepke.So we Googled his name along with Novum Pharma. His LinkedIn profile popped up, indicating that he is the cofounder and chief business officer. Okay, but we still didn’t have any contact info. Interestingly, a little further down the Google page, Toepke is listed as a member of the executive team at Avondale Strategic Partners, which is based in Chicago.That firm describes itself as a business advisory consultant and when we called the phone number, the recorded voice answered by saying we had reached the mailbox for … Novum Pharma. We shouldn’t have been surprised, though, because the address Novum used elsewhere on the Indiana state site matches the Chicago address where Avondale is located.So we turned our attention to the Illinois state government site to search for Novum and, after poking around, found the names of five people who are listed as managers.One of them is Todd Smith. His LinkedIn profile describes him as the Novum chief executive and notes that he was once executive vice president and chief commercial officer at Horizon Pharma. He was in that post when Horizon bought the rights to a pain drug from AstraZeneca — and shortly afterward, raised the list price  by 597 percent.Sound familiar?Smith did not immediately return a call seeking comment. All three contain pharmaceutical ingredients, but there is a twist — they also include aloe, a common herbal remedy.  (When it bought the gels from Primus Pharmaceuticals, Novum also bought a patent to use aloe for prevention and treatment.) There are no generic versions, so the Novum sales team has an open field to convince doctors to write lots of prescriptions, even though the prescribing information acknowledges that two of the gels are only “possibly effective.”With an army of mostly young and attractive sales reps (type in “Novum Pharma” on LinkedIn to see for yourself), getting doctors to write scripts may not be too difficult.Still, we wanted to know more about the rationale for the price hikes, which were first reported by The Financial Times.A Novum spokesman sent us a statement insisting the prices were inaccurate and saying they include “thousands of dollars in extra charges” added by third-party middlemen and passed on to patients. “This practice reflects one of the many fundamental challenges inherent in the healthcare system today that add to the cost of access for patients,” the statement said.This is the same explanation Mylan Pharmaceuticals Chief Executive Heather Bresch gave for EpiPen price hikes. Newsletters Sign up for Pharmalot Your daily update on the drug industry. Leave this field empty if you’re human: Another of the names linked to Novum rang a bell, too — he was an industry contact of ours from many years ago.So we poked around some more and located his home number. Since it was dinner time, he was there when we called. He put us in touch with Toepke, although the number he gave us actually led us to someone else, who then led us to Toepke. We called Toepke a few times and he finally responded by text. What happened next? We received the statement we mentioned earlier.In short, Novum appears to be working hard to keep the lowest possible profile. But that may be more difficult now that it’s drawn public attention for huge price hikes. In fact, the company — which contracts with a manufacturer in New Jersey where its gels are actually made — may find itself held up as yet another example of a rapacious purveyor of medicines.Yes, it does offer patients assistance programs and coupons, but coupons are also controversial, since they effectively shift more of the cost on to insurers.And high prices can sometimes backfire on a company, not just because of public outrage. A study last year found that the retail prices of seven widely used medications for skin conditions more than quadrupled between 2009 and 2015 as part of a rapid increase in prices across the dermatology sector.As a result, pharmacy benefit managers are now excluding some dermatology meds from their formularies, which are used to set insurance coverage.last_img read more

How Trump was named ‘Grand Benefactor’ for a Dana-Farber gala without donating a penny

first_img The hospital says its relationship with Trump is purely business: “Using or not using Mar-a-Lago is not a statement on the presidential election,” said Susan Paresky, Dana-Farber’s senior vice president for development.But Trump’s foundation has drawn heightened scrutiny, and not everyone associated with Dana-Farber sees such a clear distinction between business and politics.“Oh Jesus,” said Dr. David Nathan, who served as president of Dana-Farber from 1995 to 2000 and now sits on the board of trustees. He burst into laughter when told by STAT about the relationship between the hospital and Trump. “My first comment is no comment.”But he continued to comment. “Poor Dana-Farber probably made a mistake getting involved with him,” he said. “But how were they supposed to know what was going to happen?”The relationship isn’t well-known at the hospital, Nathan said. “I’m there every day,” he said. “I never knew we’re getting money from Donald Trump. And I don’t think anybody in the place really knows that.”However, he said he didn’t think Dana-Farber should be criticized. “You’ve got to take money where it comes, and as long as it’s not illicit money, I think that’s fair game,” Nathan said. Dana-Farber recognized the foundation’s generosity by naming Trump an “Honorary Chair” of the fundraiser and also a “Grand Benefactor” in 2013.In 2014, Trump’s title morphed to “Grand Honorary Chair.”Each year, Trump himself contributed $0.Such honors have been examined closely since a series of stories in the Washington Post found Trump himself has not given any money to his foundation since 2008, but is still getting credit for some donations that the foundation makes.“It is customary to thank and recognize a person most associated with a foundation for that foundation’s support,” Paresky said.Each year that the fundraising gala was held at Mar-a-Lago, Dana-Farber paid about $250 per attendee to Trump’s private company for hosting the event. Between 320 and 600 attended per year, a hospital spokesperson said. That comes out to between $80,000 and $150,000 income for the Trump company each year. (Spokespeople for Dana-Farber and Trump declined to provide the exact amount paid.)Trump’s new high profile doesn’t appear to have changed the relationship.A Dana-Farber spokesperson said that an agreement has been signed for the hospital to host its 2017 gala at Mar-a-Lago.Dylan Scott contributed reporting. Donald Trump’s health is ‘excellent,’ doctor says in releasing test results PoliticsHow Trump was named ‘Grand Benefactor’ for a Dana-Farber gala without donating a penny The annual fundraising bashes that Donald Trump hosted at his Mar-a-Lago Club for the renowned Dana-Farber Cancer Institute were showy affairs, complete with poolside champagne, flamenco dancers, and Tiffany party favors.And his titles from Dana-Farber kept getting loftier: First, he was a Discovery Celebration Chair. Then a Grand Benefactor. Then a Grand Honorary Chair.Those titles did not come at a cost to Trump because he himself has not donated to the cancer center in years. His foundation, which has not included any of his own money since 2008, has given the hospital $350,000 since 2010.advertisement Please enter a valid email address. Donald Trump, bad science, and the vitamin company that went bust Alex Hogan/STAT, Getty Images Newsletters Sign up for D.C. Diagnosis An insider’s guide to the politics and policies of health care. Privacy Policy And the snowbirds give — last year, Dana-Farber raised about $1.6 million from the Mar-a-Lago event, a small percentage of the $204 million it raised in total last fiscal year. Related: By Ike Swetlitz Sept. 29, 2016 Reprints Related: Yet Trump himself may have profited from the relationship: The hospital has paid Trump’s private club up to $150,000 a year since 2011, and once before in 2008, to host the fundraising gala.The relationship between Trump and Dana-Farber opens a window into the world of high-dollar philanthropy, where galas with celebrity guests attract wealthy donors who hop from party to party on the social circuit. Many hospitals make a point of hosting events in Palm Beach, where many wealthy spend the winter; the Cleveland Clinic’s Florida arm hosted a fundraiser at Mar-a-Lago this year and will be back in 2017, according to its website.advertisement Leave this field empty if you’re human: Dana-Farber’s galas at Mar-a-Lago were lavish affairs, as described in hospital newsletters. In 2011, “a speciality dessert parade” was followed by a Jennifer Hudson concert. The next year, “the event began with poolside champagne and caviar.”Donald and Melania Trump “welcomed guests to their exclusive venue,’’ a Dana-Farber newsletter said about one of the events. The newsletter included a note from Paresky commending the Trumps’ “leadership.’’When asked the nature of that leadership, Paresky said that “the Trumps agreed to lend their name to the event.”The hospital’s fundraising staff and a volunteer committee do the actual hands-on planning for such parties, she said.Some who have attended the fundraisers said they believe Trump’s presence is good for Dana-Farber.“I think that his being associated with it is a plus,” said Sandra Bornstein, a Palm Beach resident who attends the fundraiser regularly. He’s “extremely friendly and nice to be around,” she said.Sandra and her husband, Richard Bornstein, give about $5,000 each year at the Dana-Farber fundraiser. They are Trump supporters, and Richard Bornstein said he has contributed to Trump’s campaign.A Dana-Farber doctor who presented research at a 2012 Mar-a-Lago dinner said that there isn’t much of a relationship at all between the Republican presidential candidate and the hospital.“I don’t think there’s a significant there there,” said Dr. George Demetri, senior vice president for experimental therapeutics at Dana-Farber. He saw Trump at some of the Mar-a-Lago events and not at others. Once, he got a photo with the celebrity.Demetri’s main impression: “He’s very tall.”The Trump Organization did not respond to specific questions from STAT. The accounting firm listed on the Trump Foundation’s tax forms also did not respond to a request for comment. A Trump campaign spokesperson did not answer specific questions about the Dana-Farber donations but said the Trump Foundation “is proud to make the contributions to such a reputable and worthy organization.”Dana-Farber stands out as receiving a large percentage of the Trump Foundation’s money. The foundation gave $200,000 to the hospital in 2012, which made up about 12 percent of its charitable contributions that year.The foundation donated another $100,000 to Dana-Farber in 2013 and then gave $25,000 in each of the next two years. Tags Dana-Farber Cancer InstituteDonald Trumpphilanthropypolicylast_img read more

Canceling the Zika public health emergency was the wrong thing to do

first_img By Lawrence O. Gostin Nov. 25, 2016 Reprints About the Author Reprints Related: Related: Although understandable, it is disconcerting that the WHO terminated the Zika emergency so quickly. Zika, with its effect on mothers and babies, has an enormous political — not to mention economic, social, and moral — dimension.Calling off the Zika emergency means dismantling the Zika Emergency Committee. That in itself is a handicap to the global response because the committee, chaired by Dr. David Heymann, has been a strong, intelligent, and powerful voice that kept Zika on the front burner.Ebola taught us that the world is woefully unprepared for epidemics and that, in addition to causing death and suffering, epidemics cause enormous economic and social upheaval.Declaring an outbreak to be a public health emergency of international concern sounds the alarm to the world to be watchful and prepared to act with manpower, funding, and political support. Discontinuing the alarm too soon sends the opposite signal, and could be an excuse for political leaders to pull back on national and global preparedness and response. To his credit, Dr. Peter Salama, executive director of the WHO’s health emergencies program said, “Zika is here to stay, and the WHO’s response is here to stay.” That is the right sense of urgency, but sadly the WHO has given a subtle signal that the world can go on with business as usual.Lawrence O. Gostin, JD, is University Professor at Georgetown University in Washington, D.C., where he directs the O’Neill Institute for National and Global Health Law. Juliana da Silva holds her daughter Maria, who was born with microcephaly, inside their house in Alcantil, Paraiba state, Brazil. Felipe Dana/AP WHO declares Zika public health emergency over, though threat remains @LawrenceGostin The World Health Organization did the right thing back in February when it declared the Zika outbreak to be a public health emergency of international concern. It did the wrong thing last week when it ended the emergency.I say that for several reasons, not least of which is the signal given by the latest declaration: that Zika is no longer a pressing global concern.A legal technicality. I understand why the WHO Emergency Committee terminated the emergency. It felt obliged to follow the International Health Regulations, a move likely to set a precedent for future outbreaks. Zika is now endemic, and has been for many years. The major spread of the disease in Latin America and the Caribbean was an important reason to declare an emergency. Another was that the clusters of children born with small heads and major cognitive problems (microcephaly) were extraordinary events that required urgent research. The Emergency Committee felt that once those extraordinary events were confirmed as being linked to Zika and that the Olympics, which required emergency recommendations, were over, the requirement for a public health emergency of international concern — an unusual or unexpected event of international concern — was no longer met.advertisement Tags policypublic healthZika Virus As a matter of law, the WHO director-general has considerable discretion on how to interpret the international health regulations that define public health emergencies of international concern. Zika offered a perfect opportunity to use that discretion. Moreover, the WHO has never been consistent in its interpretation of these regulations, as I describe later about polio and MERS. Too early. The southern regions of the globe will soon enter the summer season, which is peak time for mosquito breeding and biting. So far, there are no indicators that Zika won’t reemerge with a vengeance. And those regions — Latin America, southern Asia, and southern Africa — tend to have poor countries that are least prepared to fight a Zika epidemic.advertisement Lawrence O. Gostin No vaccine. Despite hard and sustained work by research teams around the world, a vaccine against Zika is not on the horizon. Calling off the emergency without the means to prevent an epidemic doesn’t make sense.Harmful signal. Despite the potentially devastating effect of a Zika infection — babies born with microcephaly — the world has devoted scant political and economic resources to this disease. Declaring that the emergency is over will be a signal to the world that it is all right to pull resources back from fighting Zika, no matter what the WHO says. Canceling the emergency lets uninformed politicians say, “It’s no longer an emergency. Let’s devote the funds to other priorities.” That’s a likely scenario for the incoming Trump administration, which has shown its antipathy, if not hostility, to global and United Nations institutions.Deciding that the outbreak of a disease is or is not a public health emergency of international concern should be squarely based on science. Yet all too often it has a political dimension as well. In May 2014, for example, the WHO declared an emergency for polio, even though only a small number of cases had emerged. That emergency is still in effect. The Gates Foundation, Rotary International, and other politically powerful organizations have poured enormous resources into polio eradication. A year earlier, the WHO did not call an emergency for Middle East respiratory syndrome (MERS), even though the virus that causes MERS fulfilled all the requirements for an emergency. Saudi Arabia is the epicenter of MERS, and it is widely believed the Saudi government exerted political influence to prevent an emergency declaration. PoliticsCanceling the Zika public health emergency was the wrong thing to do Scientists zero in on microcephaly risk for babies born to Zika-infected mothers [email protected] last_img read more

From ovary to uterus: studying the overlooked transport in between

first_img By Ike Swetlitz Feb. 7, 2017 Reprints From ovary to uterus: studying the overlooked transport in between Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED In the Lab Alex Hogan/STAT What is it? Log In | Learn More Tags research STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. What’s included? Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Five years ago, in a laboratory in Durham, N.C., Joy Winuthayanon lost a mouse embryo and found her calling: studying the oviducts, oft-neglected in the research world of reproductive biology, yet essential for fertilized eggs to make it into the uterus. “Most of the people study the ovary or the uterus,” said Winuthayanon, an assistant professor of molecular bioscience at Washington State University. “And the oviduct is just kind of there, being a tube.” GET STARTEDlast_img read more

Q&A: 21st Century Cures Act may favor ‘speed over science’

first_img Q&A: 21st Century Cures Act may favor ‘speed over science’ The 21st Century Cures Act, signed into law in the last days of the Obama administration. Chip Somodevilla/Getty Images Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED About the Author Reprints Log In | Learn More STAT staff What is it? STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.center_img [email protected] Pharmalot The 21st Century Cures Act promises to ramp up funding for biomedical research while also loosening regulations governing drugs and medical devices. Supporters say it will speed up approval of new treatments, while critics are concerned that the safety and effectiveness may be compromised.Before a panel discussion on the law hosted by the Harvard T.H. Chan School of Public Health and STAT, Ed Silverman, STAT senior writer and Pharmalot columnist, interviewed Aaron Kesselheim, associate professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, on Facebook live. The full Q&A video is here; the panel discussion will be available here. GET STARTED By STAT staff Feb. 27, 2017 Reprints What’s included? Tags drug developmentpolicyresearchlast_img read more

A Chinese billionaire may get a monopoly on a cancer drug backed by U.S. taxpayers

first_img What is it? Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Log In | Learn More Lydia Polimeni/NIH STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. GET STARTED @Pharmalot Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED What’s included? About the Author Reprintscenter_img A Chinese billionaire may get a monopoly on a cancer drug backed by U.S. taxpayers The U.S. National Institutes of Health plans to award an exclusive license for promising medical technology that was funded by U.S. taxpayers to a company controlled by a Chinese billionaire.In a notice posted on the Federal Register on Monday, the agency proposed giving patent rights for antibody drugs that would be used to treat liver cancer to Salubris Biotherapeutics, a division of a company that is largely owned by Ye Chenghai, a former mayor of Shenzhen, China, who is the 51st richest person in China, according to Forbes. Ed Silverman [email protected] Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Pharmalot By Ed Silverman Aug. 9, 2017 Reprints Tags drug developmentlegalpharmaceuticalsSTAT+last_img read more

The race for a Zika vaccine slows, a setback for efforts to head off future outbreaks

first_imgLeave this field empty if you’re human: Rajeev Venkayya, president of Takeda’s vaccine business unit, agreed.“The Sanofi news was news to us,” said Venkayya. “It’s a reminder of how challenging vaccine development can be.”The Sanofi project — a collaboration with the Walter Reed Army Institute of Research — was the second Zika vaccine project the company had shelved. Last year it stopped work on a Zika vaccine it was funding from its own coffers.In the early days, it looked as if the Sanofi project had a head start over the Takeda effort to make an inactivated whole virus vaccine. U.S. Army scientists at the Walter Reed Institute had completed the first stage in the vaccine creation — they had invented the prototype. They were even conducting the first stage of human testing, in conjunction with the National Institute of Allergy and Infectious Diseases.Sanofi licensed the vaccine from them, leaving it up to the company to do the second phase of testing and to learn to make the recipe consistently and on a larger scale.That’s the part that seems to have taken longer than expected. The initial development timelines had been set when Zika was a global health emergency. But the World Health Organization downgraded that status in November 2016. As the Zika outbreak seemed to sputter out, some of the urgency went with it.“I would say that we started out with very, very aggressive timelines to try and respond to an emergency situation,” Heinrichs said. “And as that emergency lessened, we readjusted our timelines to really understand the product and to be able to develop a robust system of manufacturing. And because of that, timelines were adjusted.”At the same time, Sanofi came under fire from some lawmakers who were angry its contract with Walter Reed did not include a guarantee the vaccine would be sold at an affordable price. A company that felt it had stepped up in answer to a call for help felt stung by the criticism.“I would say that that’s not the major driving force of us getting out. … But it certainly didn’t help,” Heinrichs said. Can Zika infection attack the brains of newborns? Scientists head to field for answers Tags infectious diseaseVaccinesZika Virus Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson By Helen Branswell Sept. 13, 2017 Reprints @HelenBranswell Early this month, the vaccine maker Sanofi Pasteur quietly pulled the plug on its Zika vaccine efforts, a reflection of some complications in the development of the vaccine as well as of evaporating market prospects and limited U.S. government funding.The company said the latter factor — word that the government would not fully fund the vaccine work — was the key. Without full government funding of the program “we could not continue development of a Zika vaccine,” said Jon Heinrichs, the Sanofi executive who led the effort. “We still don’t see that this would be a profitable vaccine for Sanofi Pasteur.”advertisement The development of a type of Zika vaccine that authorities had hoped to usher to the market has proven more challenging than some scientists and pharmaceutical companies had expected, people involved in the research have told STAT, posing a setback for efforts to avoid future outbreaks of the disease.Although vaccines typically take years to produce, test, and license, U.S. health officials had voiced confidence that Zika would not be a difficult target, and some predicted that a vaccine could be made and fully tested, ready for Food and Drug Administration assessment, within two to three years. Others predicted a licensed Zika vaccine could be available sometime in 2020.Even the more cautious forecast now seems optimistic.advertisement Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. Please enter a valid email address. In the LabThe race for a Zika vaccine slows, a setback for efforts to head off future outbreaks These are newer approaches. To date there have not been any mRNA or DNA vaccines approved for use in people, so the FDA does not have the same level of experience with them. If they proceed, the licensure process would likely take longer.And all the Zika vaccine projects — even the inactivated whole virus product — face a huge hurdle at this point. In order to persuade vaccine regulators to license a vaccine, manufactures normally have to provide evidence that the product works — that vaccinated people are protected from the target illness.With the collapse of the Zika epidemic, it’s not practical at this point to stage the type of trial that would be needed to show a vaccine works. These trials are expensive as it is, and with low levels of disease, it would take years to generate the proof.Viruses like Zika typically flare and subside, so time may solve that problem. Or the FDA may be willing to consider an emergency use request based on other kinds of data.Bright remains insistent that at least one Zika vaccine needs to be made.“We do not want to leave Zika vaccines in the same freezer where we left SARS years ago or we left Ebola years ago and be caught off guard,” he said. “We want to continue development.” A glass model of Zika virus. Matt Cardy/Getty Images Senior Writer, Infectious Disease Helen covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. Venkayya said Takeda feels added responsibility to get its vaccine through testing and development. It isn’t thinking, he said, about the market prospects — surprising given that at the moment they seem tenuous. But he admitted that without BARDA funding, Takeda would also be out of the Zika vaccine race.“The fact that BARDA has come in and de-risked this program by funding a substantial portion of the cost — not all the cost, but a substantial portion of the cost — makes this a viable program for us,” he said.Meanwhile, there are other companies still working on a Zika vaccine.BARDA is also funding research by Moderna Therapeutics, which is already doing initial safety and dose-setting testing of a novel vaccine using what is called messenger RNA to induce an immune response to the Zika virus.Mike Watson, who is president of Valera — Moderna’s infectious diseases unit — said the company should have some immunological data from the trial toward the end of the year.Inovio Pharmaceuticals has partnered with GeneOne Life Science on a DNA vaccine. That vaccine was the first to be tested in people. Results of early trials are promising, said Inovio CEO Joseph Kim, who added the company hopes to publish the results in a journal soon. The company is currently looking for funding to conduct larger studies.The National Institute of Allergy and Infectious Diseases has developed and is testing a DNA vaccine as well; it’s already in the second phase of human trials, one of the few vaccines to date to get that far.But DNA and mRNA vaccines are more sophisticated confections than inactivated whole virus vaccines. And while both types are further along than the whole virus vaccines at this point, they will face challenges further along in the process. Trending Now: Related: About the Author Reprints Sanofi quietly pulls the plug on its Zika vaccine project Related: Testing delays that stemmed from adjustments needed for the vaccine may have affected Sanofi’s ability to gain more funding for the project. Both Sanofi and a competitor working on a similar style of Zika vaccine found they had to lengthen their projected development timelines.The Biomedical Advanced Research and Development Authority, the division of the Department of Health and Human Services that is funding Zika vaccine development, met over the summer with all the companies receiving Zika funding to assess where each project stood. It decided that Takeda Pharmaceuticals, which is working on the same type of vaccine, was further along in its effort than Sanofi.“We have only been provided limited funds and we want to be able to take at least one vaccine candidate as far as we can with the funding and support that we have available to support Zika vaccines,” said BARDA Director Rick Bright. “And so it’s important that we have a portfolio approach.”Takeda reported that its first human testing would begin this fall. But Sanofi expected that it would take the company more time to be ready to get to that phase, Bright said.“We learned that we needed to do some additional work to really understand our product before we were comfortable moving quickly into clinical studies,” Heinrichs told STAT.Creating a new vaccine is a bit like inventing a new cake recipe from scratch. You have to figure out how to make it, test it to make sure the recipe works, then build and equip a production facility that can pump out identical versions of the cake batch after batch. And before the cakes can be sold, the FDA must assess the product and inspect and certify the bakery.Sanofi and Takeda were both working on what might have been considered the standard white cake version of a vaccine — using an inactivated or killed Zika virus to generate antibodies, with a simple adjuvant added to boost the immune response.Inactivated whole virus vaccines have been made for decades, to protect against a range of diseases. They have a clear safety record and the FDA knows a lot about how these types of vaccines work. A vaccine made using this recipe would likely sail through the licensure process. That’s why Sanofi opted for this approach, and why BARDA was funding it.But this white cake of a vaccine hasn’t been quite as simple to make as people expected when the race to develop a Zika vaccine was launched by the Obama administration last year.“Two years ago — basically early February 2016 — people thought it would be easy and straightforward to make a Zika vaccine based on all the years of knowledge we had in making other vaccines for other flaviviruses such as dengue, etc.,” Bright told STAT. “We did learn a lot from those other experiences, but no vaccine is easy to make.” Helen Branswell Privacy Policylast_img read more