Pharmalot, Pharmalittle: PhRMA ups lobbying spending, hepatitis C drug report

first_imgPharmalotPharmalot, Pharmalittle: PhRMA ups lobbying spending, hepatitis C drug report By Ed Silverman Jan. 22, 2016 Reprints @Pharmalot And so, another working week is about to draw to a close. Not a moment too soon, yes? As always, this is our treasured signal to daydream about weekend plans. Unfortunately, we foresee spending considerable time fortifying our castle from a looming snowstorm. So picture this — a shovel in one hand and a cup of stimulation in the other. And what about you? Depending upon your locale, you may also encounter the same conditions. Are you ready? As for the rest of you, perhaps this is a good time to catch up with someone special, take a nap, or simply take stock. Whatever you do, have a grand time. But be safe. See you soon …Amid increased rancor over prescription drug prices, the Pharmaceutical Research and Manufacturers of America spent more on lobbying last year, The Hill says. Citing data from the Center for Responsive Politics, the trade group shelled out $18.3 million in 2015, up from $16.5 million the year before. And last year was also the first since 2009 since the trade group increased its lobbying spending.Senators Ron Wyden and Chuck Grassley are asking health care providers and patient groups for reactions to their recently released report on the price of the Sovaldi hepatitis C treatment, which triggered anger over the cost of medicines. Citing a raft of documents, the lawmakers concluded that Gilead Sciences placed profits before patients in setting the price. In their letter, they ask for thoughts on value and pricing transparency, among other things.advertisement [email protected] Alkermes reported that two late-stage studies of a depression treatment failed to meet their primary endpoints, wiping out nearly $4 billion from its market value, The Wall Street Journal informs us.Stefano Pessina, the Walgreens Boots Alliance chief executive officer, believes that drug prices should be lower for consumers, Bloomberg News writes.The Food and Drug Administration approved Amgen’s Kyprolis cancer med in combination with other therapies to treat patients with multiple myeloma, Reuters reports.The UK’s National Institute for Health and Care Excellence, the cost-effectiveness overseer, endorsed the use of Bristol-Myers Squibb’s Opdivo in skin cancer patients, Bloomberg News tells us.Nephron Pharmaceuticals plans to lay off 250 employees from its Orlando, Fla., headquarters, where manufacturing is being shifted out of state, The Orlando Business Journal writes.Pfizer’s Ibrance breast cancer treatment has completed the first step to joining the UK’s Early Access to Medicines Scheme, Pharma Times writes. Ed Silvermancenter_img About the Author Reprints Alex Hogan/STAT AstraZeneca chief executive officer Pascal Soriot believes the drug maker would not have made as much progress in developing new cancer drugs had it been acquired by Pfizer, The Financial Times writes. While defending against the takeover bid, he made some aggressive growth targets, such as increasing revenue to $40 billion by 2023, but Soriot maintained that the company is on track to reach that goal.Martin Shkreli asked a congressional committee seeking his testimony on drug pricing to guarantee it will not be used in a federal prosecution of securities fraud, The Wall Street Journal reports.advertisement Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Tags drug pricesMartin ShkreliSovaldilast_img read more

To split or not to split? One Wall Street wag thinks Pfizer may remain intact

first_img Please enter a valid email address. After failed Allergan merger, Pfizer once again considers splitting up the company Of course, he pointed out this probably isn’t a new realization. In fact, he suggested this may explain why Pfizer turned its back on the idea and, instead, pursued two failed deals — with AstraZeneca and then Allergan — in order to lower its corporate tax rate. “This again begs the question, why bother to split?” he wrote.After all, Pfizer can point to the success of the new Ibrance breast cancer treatment, which generated $723 million in sales last year, its first year on the market, and the Prevnar vaccine franchise, which notched $6.25 billion in revenue in 2015. There are also added sales from the Hospira acquisition, which once prompted further speculation about a split.Interestingly, Anderson canvassed big investors, and 51 percent expect Pfizer to pursue a split. Meanwhile, 49 percent believe the drug maker would rely on more mergers and acquisitions and business development deals for growth if a split is rejected. Read acknowledged as much during a recent investor conference, he noted.Ironically, this may bring Pfizer full circle, because this is, essentially, “an extension of the strategy the company pursued over the last 15-plus years,” Anderson wrote. And “this is potentially troubling, because it was this same strategy that caused Pifzer to consider splitting up in the first place.”Just the same, Anderson suggested Pfizer executives may reject a split, since the stock is inexpensive relative to similar drug makers and offers total annual shareholder return of about 9 percent, when considering the dividend and earnings per share growth. And with healthy cash flows, he added, Pfizer can “continue to buy up its growth rate through acquisitions, something that investors in Pfizer generally seem okay with.”We asked Pfizer for comment and will pass along any reply. Leave this field empty if you’re human: [email protected] Related: By Ed Silverman July 18, 2016 Reprints Ed Silverman After its deal to acquire Allergan fell apart three months ago, Pfizer executives indicated they may split the company into different parts. The idea, which Pfizer first floated five years ago, would presumably unlock, or bolster, shareholder value by creating two different entities to produce older drugs and another that would focus on newer medicines.A decision is expected later this year, but one Wall Street analyst is questioning whether the big drug maker will follow through.In a note to investors, Sanford Bernstein analyst Tim Anderson suggested there are several reasons for the uncertainty. For one, Anderson wrote that Pfizer Chief Executive Ian Read last month alluded to the possibility that splitting up the company could disrupt cash flow and weaken the strength of its balance sheet.advertisement Why else may Pfizer reject a split? Using what he called a sum-of-the-parts analysis, Anderson suggested a split may not unlock “substantial additional” value for shareholders, after all. He forecasts a value of about $36 a share, which is roughly in line with the current stock price. And unlike in 2011, when growth prospects seemed fuzzy, Pfizer seems to be better positioned.advertisement Privacy Policy @Pharmalot Newsletters Sign up for Pharmalot Your daily update on the drug industry. PharmalotTo split or not to split? One Wall Street wag thinks Pfizer may remain intact Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. About the Author Reprints Spencer Platt/Getty Images Tags AllerganAstraZenecaPfizerlast_img read more

A year of arm-twisting: How the drug industry flexed its lobbying muscle in 2016

first_imgPolitics 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. Unlock this article — plus daily intelligence on Capitol Hill and the life sciences industry — by subscribing to STAT+. First 30 days free. GET STARTED What is it? GET STARTED In his harsh comments about the drug industry at a press conference earlier this month, President Trump declared that “pharma has a lot of lobbies and a lot of lobbyists and a lot of power.”But how much, exactly? STAT analyzed lobbying disclosure filings updated this week to build an in-depth portrait of how the drug industry wielded its influence on the federal government in 2016.All told, the industry’s two big trade groups spent a collective $29 million lobbying the federal government last year. And the top 15 pharma companies (by one measure) collectively spent an additional $80 million. Both figures are roughly consistent with 2015. 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 By Rebecca Robbins Jan. 25, 2017 Reprints A year of arm-twisting: How the drug industry flexed its lobbying muscle in 2016 What’s included? Alex Hogan/STAT Tags biotechnologyCongresspharmaceuticalspolicySTAT+White Houselast_img read more

The latest deal for a priority review voucher suggests prices are finally falling

first_img By Ed Silverman Feb. 21, 2017 Reprints Ed Silverman About the Author Reprints In a noteworthy deal, Gilead Sciences agreed to pay $125 million to Sarepta Therapeutics for a priority review voucher. But one Wall Street analyst expressed disappointment over the price tag and suggested the deal raises questions about how much these controversial vouchers can fetch going forward.Priority review vouchers, you may recall, were created several years ago by the Food and Drug Administration to encourage development of pediatric and tropical disease medicines. These vouchers are valuable to drug makers, because companies can later redeem them when seeking approval from the FDA for another medicine to treat any illness. And the agency is obligated to review the other drug in six months instead of the standard 10 months. 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. Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED AP What is it? @Pharmalot GET STARTEDcenter_img Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Log In | Learn More The latest deal for a priority review voucher suggests prices are finally falling [email protected] Pharmalot 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. What’s included? Tags FDApharmaceuticalsSTAT+last_img read more

Why were there fewer microcephaly cases from Zika last year?

first_img Ethics panel blocks proposed Zika vaccine research By Helen Branswell March 29, 2017 Reprints The authors also noted a third possibility — that women in the region who had seen the possible outcome of a Zika infection in pregnancy might have either avoided pregnancies in large numbers or terminated pregnancies. But if the maternity wards of hospitals in the region had emptied out in 2016, the world would have heard about it by now.“If there was a huge effect like that, it would have been big news very quickly. It would have been very visible,” Dye said.If the theory — that Zika blew through Northeastern Brazil in one wave — is correct, it likely means so many people there were infected in 2015 that there were few still vulnerable to the virus in 2016.  In some ways, that may be a good sign; it might suggest Zika outbreaks are swift.But it doesn’t mean the virus is done. More likely, said Dye, is that Zika will return after births create pools of people who have no immunity to the virus, hitting perhaps when people aren’t expecting it.“But we really can’t rule anything out. And we’re ready for further surprises on Zika virus,” he said. HealthWhy were there fewer microcephaly cases from Zika last year? Helen Branswell When the data were slotted into a graph, the discrepancy was plain as day. In 2015, a large spike in GBS cases was followed about 23 weeks later by a wave of microcephaly births. But a corresponding spike in GBS cases in early 2016 was not.NEJMZika infection can trigger GBS, a progressive paralysis from which most people recover. And Zika infection in pregnancy can attack the fetus, leading to microcephaly and other neurological birth defects.Chikungunya infection can cause GBS. But chikungunya infection in pregnancy is not known to cause microcephaly.“This is not a statement of fact and proof. This is the best hypothesis,” said Christopher Dye, senior author and an epidemiologist with the WHO.“The cases in the first year, back in 2015, were really Zika cases. And that’s why we saw the microcephaly in 2015. But in 2016, it was predominantly chikungunya, not Zika, and that’s why we saw Guillain-Barré, but not microcephaly.” Senior Writer, Infectious Disease Helen covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. Of the many mysteries that remain about the Zika virus and its attack on the Americas, perhaps the most puzzling one relates to the bizarre distribution of babies born with Zika-induced microcephaly.After so many such births were recorded in Northeastern Brazil in the last quarter of 2015, the country — and other places where the virus fanned out to from Brazil — braced themselves for a similar tsunami in 2016. But it didn’t materialize — at least not to the same degree.A new and intriguing letter to the New England Journal of Medicine offers a theory for how to explain the missing microcephaly cases, the babies that were predicted to be born in Northeastern Brazil after Zika’s second wave of infection in the early part of 2016.advertisement The authors suggest the region’s first wave of Zika may have been its only wave of Zika to date. Something that caused similar illness, likely the chikungunya virus, was probably responsible for the high level of fever and rash illnesses Brazil recorded in 2016, they theorized.The authors — from the Brazilian ministry of health, the Oswaldo Cruz Foundation, the Pan American Health Organization, and the World Health Organization — used information from two databases that capture cases of microcephaly and Guillain-Barré syndrome.advertisement Dye said based on reports of rash and fever in Northeastern Brazil in early 2016, it was expected that about 1,000 babies would be born with Zika-induced microcephaly from late summer onward. Instead, about 80 were recorded in the region.For many diseases, this type of data mining and hypothesizing would not be needed. During a wave of illness, testing of the sick would show what was infecting them. And studies looking at the blood of people who had previously been ill would indicate how broadly a pathogen had spread.But one of the vexing dilemmas of the Zika virus is that it so closely resembles related viruses that testing cannot always tell whether a person is infected with Zika or something similar, like dengue. Widespread testing hasn’t been done, Dye said.He and his co-authors acknowledged there could be other explanations. For instance, from the earliest stages of the Zika outbreak in the Americas, questions were raised about the high number of microcephaly cases in Northeastern Brazil. No other place experienced so many, leading people to ask whether there was something else there — a co-factor — that exacerbated the impact the virus had on the population of the region.Dr. David Heymann, who was the chairman of the WHO’s Zika emergency committee — which has been disbanded — told STAT the committee looked at issues like population crowding in the cities of Northeastern Brazil and the nutritional status of people there, among other things.But no clearly obvious co-factor came to light. And some — questions about local use of insecticides — were ruled out, Dye said.The letter’s authors cannot exclude the possibility that there was a co-factor there, Dye said. But the fact that there were few microcephaly cases the following year means that the co-factor would have been missing in 2016 — and that makes it less likely. Zika threat isn’t over, CDC director warns pregnant women thinking about beach vacations Related: Ana Livia, who was born with microcephaly, is held by her mother in Recife, Brazil. Mario Tama/Getty Images Related: About the Author Reprints @HelenBranswell Tags infectious diseasepublic healthvirologyZika Viruslast_img read more

How to tell if the price is right on your next prescription

first_img Log In | Learn More About the Author Reprints Filling a prescription is no longer the simple errand you run after a doctor visit.With drug prices rising and insurance coverage shrinking, it pays to ask questions and do a little research before handing over your insurance card at the pharmacy counter. Having coverage offers no guarantee that you’re getting the best price for your medicine. GET STARTED Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED What is it? Rich Pedroncelli/AP By Associated Press Aug. 23, 2017 Reprintscenter_img How to tell if the price is right on your next prescription What’s included? 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. Associated Press 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. Pharma last_img read more

Vertex gets regulator sign-off on accelerated cystic fibrosis drug trial

first_img Log In | Learn More 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. Vertex gets regulator sign-off on accelerated cystic fibrosis drug trial By Adam Feuerstein Feb. 21, 2018 Reprints About the Author Reprints Biotech Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+. First 30 days free. GET STARTED GET STARTED 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. Tags biotechdrug developmentSTAT+center_img What is it? Vertex Pharmaceuticals (VRTX) reached an agreement Wednesday with the Food and Drug Administration that shaves nine months off the length of its next pivotal cystic fibrosis clinical trial.The speedy trial design means the first of Vertex’s three-drug regimens for cystic fibrosis could have top-line results by the end of this year or early in 2019 — faster than anticipated. The company’s accelerated timeline also makes it harder for any of its cystic fibrosis competitors to keep pace. Craig F. Walker/The Boston Globe Adam Feuerstein Senior Writer, Biotech Adam is STAT’s national biotech columnist, reporting on the intersection of biotech and Wall Street. He’s also a co-host of “The Readout LOUD” podcast. [email protected] @adamfeuerstein What’s included?last_img read more

More GOP lawmakers urge U.S. trade officials to lean on Colombia over drug approvals

first_img Tags pharmaceuticalsSTAT+ Log In | Learn More What’s included? [email protected] @Pharmalot More GOP lawmakers urge U.S. trade officials to lean on Colombia over drug approvals Alex Hogan/STAT Pharmalot 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. 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.center_img Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Still more Republican lawmakers are urging the U.S. trade representative to require Colombia to change its laws governing drug approvals before supporting the country’s membership in the Organization for Economic Cooperation and Development, an intergovernmental trade group.In a letter late last week, U.S. Reps. Tom Rice (R-S.C.) and Patrick Meehan (R-Pa.) argued that the Colombian government must alter a national development plan, because it differs from World Health Organization standards by tying marketing approval for approving drugs to pricing criteria, which they argue is not used by other OECD countries. There are three dozen countries in the group. GET STARTED About the Author Reprints By Ed Silverman April 16, 2018 Reprints Ed Silverman Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED What is it?last_img read more

Pharmalittle: Roche suffers a setback in a cancer trial; Trump wants to shift Medicare B drugs to Part D

first_img Ed Silverman Rise and shine, everyone, another busy day is on the way. And this is an even busier time than usual, thanks to recent intriguing developments. There is only one thing to do, of course, when events threaten to overtake you — fire up the coffee kettle and quaff some cups of stimulation. We are relying on chocolate cherry decadence this morning, for those who track this sort of thing. Meanwhile, here are a few items of interest. Hope your day is interesting and productive. And do drop us a line if you come across anything interesting, such as curious payments to fixers …President Trump on Friday plans to outline a series of initiatives aimed at curbing drug prices that will be accompanied by proposed rules and a broad request for input from manufacturers, health providers, patients, and others, according to The Wall Street Journal. The administration wants to move some drugs out of Medicare Part B, but the proposals are expected to fall short of earlier ideas backed by Trump, including letting Medicare use its enormous buying power to negotiate drug prices directly with suppliers. By Ed Silverman May 10, 2018 Reprints [email protected] Tags Donald Trumpdrug pricingfinancejobsMedicarepharmaceuticalspharmalittle 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. Pharmalittle: Roche suffers a setback in a cancer trial; Trump wants to shift Medicare B drugs to Part D What is it? What’s included? About the Author Reprintscenter_img Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. GET STARTED Log In | Learn More Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Pharmalot @Pharmalot 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. Alex Hogan/STATlast_img read more

New drug for spinal muscular atrophy shows positive results — and could be a threat to Biogen

first_img 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. Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED New drug for spinal muscular atrophy shows positive results — and could be a threat to Biogen Adam Feuerstein By Adam Feuerstein June 18, 2018 Reprints 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 [email protected] @adamfeuerstein Senior Writer, Biotech Adam is STAT’s national biotech columnist, reporting on the intersection of biotech and Wall Street. He’s also a co-host of “The Readout LOUD” podcast. About the Author Reprints GET STARTED An experimental, oral medicine originally developed by PTC Therapeutics and now licensed to Roche improved the muscle function of babies with a fatal form of the rare, genetic disease known as spinal muscular atrophy, according to preliminary results from a clinical trial presented Saturday.More testing needs to be done to confirm these findings, but if they hold up, the new drug from PTC and Roche could be a significant competitive threat to Spinraza, the first chronic drug approved to treat SMA patients, marketed by Biogen. Biotech What’s included? Tags biotechnologydrug developmentpharmaceuticalsSTAT+last_img read more