It’s been almost one year since Congress and the Biden administration passed the Inflation Reduction Act (IRA), and so far leaders in the biopharma industry have not been shy in voicing their complaints. As some drug companies and trade groups take to the courts with their arguments, Genentech CEO Alexander Hardy is publicly warning about the “unintended consequences” of the IRA. In a recent interview with Fierce Pharma, the Genentech chief described his concerns with measures included in IRA, which particularly affects the oncology sector, he says. Under the IRA, small molecule drugs are subject to Medicare drug-pricing negotiations after 9 years, while biologics get 13 years on the market before they’re included in the program. Regardless of a drug’s classification, Hardy noted that those timelines squeeze companies as they work to study their drugs in additional indications and reach more patients. Companies like Genentech regularly work to move their ...
David Epstein’s short tenure as Seagen’s CEO will likely end soon with the antibody-drug conjugate specialist’s sale to Pfizer. After a rich career spanning companies of various sizes, Epstein is keeping an open mind about where he might head next.“I will hopefully make new drugs somewhere else,” Epstein said in a recent interview on the sidelines of the American Society of Clinical Oncology’s annual meeting. “I don’t know where that will be.” Throughout his time in biopharma, Epstein has worn many hats. He’s known for building Novartis’ oncology unit and leading the Swiss giant’s larger global pharma business. He fostered startups for five years at Flagship Pioneering before taking the reins at Seagen in November. Those roles have given him experience in almost every therapeutic area and in both drug development and commercialization. That kind of resume opens a lot of possibilities—although going back to Flagship isn’t his plan right ...
By Tristan Manalac Pictured: Cancer patient in bed looking out window / iStock, Ridofranz The entry of biosimilars promotes healthy market competition. It can reduce the prices of branded biologic medicines, according to a new study from the University of Southern California’s Leonard D. Schaeffer Center for Health Policy & Economics. The study, published online Tuesday in the journal Health Affairs, focused on Genentech’s (Roche) breast cancer treatment Herceptin (trastuzumab) and its five biosimilar competitors that entered the U.S. market starting in 2019: Amgen’s Kanjinti, Viatris’ Ogivri, Pfizer’s Trazimera, Teva’s Herzuma and Organon’s Ontruzant. Study results showed that when Herceptin’s first biosimilar competitor—Kanjinti—hit the market, its average price dropped around 21%, from $101 to $80 per 10 mg. By the second quarter of 2022, toward the end of the study’s analysis period, biosimilars maintained an average sales price of 28% to 58% of Herceptin’s pre-competition average sales price. “Trastuzumab is ...
The US House of Representatives has turned a sharp eye to drug shortages over the past few months, with hearings and new caucuses to try and dampen the situation, but another bipartisan letter sent yesterday to FDA aims to keep the pressure up on cancer drug shortages. Reps. Debbie Dingell (D-MI) and Tim Walberg (R-MI) penned the letter to FDA Commissioner Rob Califf, expressing concerns around the shortages of two commonly used chemotherapies used to treat cancer, known as cisplatin and carboplatin, which are used for lung, gynecologic and breast cancers, as well as methotrexate, which is used in treating other forms of cancer. “These chemotherapy drug shortages come amid a shortage of other critical cancer medications. Taken together, they are straining the ability of doctors to provide the best course of treatment for their patients. We are hearing directly from impacted hospitals urging immediate action to address ...
The jury has spoken, giving a unanimous “yes” to push Perrigo’s birth control tablet Opill over the counter. Wednesday, experts from a joint FDA meeting of outside experts voted 17 to 0 in favor of Opill’s over-the-counter approval pivot. If approved later this year by the FDA, Opill would become the first OTC daily hormonal birth control pill cleared in the U.S. The unanimous vote came despite a number of big questions from the FDA about the potential for Opill’s responsible over-the-counter use in the real world. The FDA does not have to follow the advice of its advisory committees when making an approval vote, though it often does. Panelists had one main question to consider. Namely: Was there “adequate information to conclude that consumers will be likely to use [Opill] properly, such that the benefits of making this available for nonprescription use … exceed the risks.” Overall, panelists concluded ...
EQRx, a high-profile startup that attempted to build a new pharmaceutical business model, will lay off a large portion of its staff and discard much of its drug pipeline in a large-scale reset announced Monday. Launched by veteran biotech venture capitalist Alexis Borisy, EQRx started up in early 2020 with grand plans to reimagine how prescription drugs are developed and priced. The company claimed it could invent or license similar, but more effective competitors to top-selling specialty medicines, such as those for cancer, and sell them for less — a vision EQRx executives used to raise more than $2 billion in funding. EQRx made some progress, licensing several cancer drugs from Chinese companies and advancing them into late-stage clinical testing. But its near-term plans were thrown into disarray by the Food and Drug Administration, which set out stricter approval standards for drugs developed and tested in China. EQRx pivoted ...
Merck on Thursday reported first-quarter revenue and adjusted earnings that topped Wall Street’s expectations, despite a steep drop in sales of its Covid antiviral treatment molnupiravir. Sales of molnupiravir plunged to $392 million during the period, down 88% from the $3.2 billion reported for the first quarter of 2022. Merck said the decrease is primarily the result of lower sales in the U.S., U.K., Japan and Australia. The company reported total revenue of $14.5 billion for the quarter, down 9% from a year earlier. But excluding the Covid drug, Merck said its revenue grew 11%. Here’s what Merck reported compared with Wall Street’s expectations, based on a survey of analysts by Refinitiv: Earnings per share: $1.40 adjusted, vs. $1.32 expected Revenue: $14.49 billion, vs. $13.78 billion expected Merck’s stock closed more than 1% higher Thursday. The shares are up more than 3% for ...
March 23 (Reuters) – Sanofi’s (SASY.PA) asthma drug Dupixent met all targets in a trial to treat “smoker’s lung”, potentially adding billions to the French drugmaker’s growth prospects, but also underscoring a heavy reliance on its bestseller. In a late stage trial Dupixent, jointly developed with Regeneron (REGN.O), led to a 30% reduction in moderate or severe acute exacerbations of chronic obstructive pulmonary disease (COPD), a potentially deadly disease marked by progressive lung function decline. Shares in Sanofi and Regeneron surged after they said in a joint statement on Thursday a Phase III trial involving 939 current or former smokers also showed improvements in lung function, quality of life and respiratory symptoms. The French group’s stock was up 5.2% at 1205 GMT, reaching a seven-month high and far outperforming the STOXX Europe 600 Health Care index (.SXDP), which was little changed. Regeneron jumped 8.6% in U.S. ...
The company discontinued about 20 early-stage projects after reviewing their strategic fit and commercial potential. Novartis said Tuesday it will discontinue or license out 10% of its clinical development projects after reviewing their strategic fit and sales potential. The Swiss drugmaker has trimmed its drug pipeline to 136 projects, down by 16 from the 152 disclosed in its fourth quarter earnings report, according to a presentation Tuesday. The biggest cutbacks came to its early-stage projects, with 19 programs cut. Half of those were early-stage programs testing drugs for solid tumors. The move comes one year after Novartis resized its business and narrowed its research focus to five core therapeutic areas — cardiovascular, immunology, neuroscience, solid tumors and hematology. It expects to save at least $1 billion annually by 2024 as a result. “We systematically looked at the pipeline, identified projects that were outside the scope ...
Closely following a Mediterranean diet may cut a woman’s risk of heart disease and death by nearly 25%, according to a new analysis of 16 studies. “This study adds to what is already known about the cardiovascular benefits of a Mediterranean diet but further reiterates that it can be equally as beneficial in women as it is known to be in men,” said lead author Sarah Zaman, associate professor at the Westmead Applied Research Centre at the University of Sydney, in an email. Heart disease is the number one killer of women and men worldwide, according to the World Health Organization. Coronary artery disease kills more than twice as many women as breast cancer in the United Kingdom, while in 2020, one in five deaths among women in the United States was because of heart disease. Yet few studies on the heart have looked specifically at women, ...
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