Pharma: Page 43
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Drug price restraints dropped as Biden prioritizes other measures
Despite majority control of Congress, it appears unlikely the Biden administration will be able to pass meaningful pricing reform, though a slimmed-down bill may still be in the works.
By Jonathan Gardner • Oct. 29, 2021 -
Merck sees up to $7B in coming sales of coronavirus pill
Executives based their projections on contracts already in place for the drug, known as molnupiravir. But sales could climb even higher if it works as a preventive treatment too.
By Jonathan Gardner • Oct. 28, 2021 -
Explore the Trendline➔
Brian Tucker / BioPharma Dive/BioPharma DiveTrendlineTop 5 stories from BioPharma Dive
Looming patent expiries this decade and intensifying competition from China are forcing drugmakers to adapt, while new opportunities open up in oncology and in neuroscience.
By BioPharma Dive staff -
Takeda reels in a cell therapy research partner with 'build-to-buy' deal
The Japanese drugmaker is acquiring GammaDelta Therapeutics, a partner since 2017, and its research on allogeneic cell therapy for cancer.
By Ned Pagliarulo • Oct. 27, 2021 -
Merck agrees to license COVID-19 pill widely through pact with patent group
The deal with the Medicines Patent Pool is meant to increase access in lower-income countries to molnupiravir, an experimental drug that could become the first oral treatment for COVID-19.
By Kristin Jensen • Oct. 27, 2021 -
With approval plans underway, Lilly's next move is to test its Alzheimer's drug against Biogen's
Alongside a new earnings report, Lilly announced plans for a late-stage study to evaluate whether donanemab is better than Aduhelm at clearing amyloid beta plaques.
By Jacob Bell • Oct. 26, 2021 -
Novartis to consider sale or separation of Sandoz business
The generic drug unit has struggled in recent years, while Novartis has moved to focus more narrowly on higher-margin branded medicines.
By Ned Pagliarulo • Oct. 26, 2021 -
Moderna vaccine safe and spurs immune response in kids, company says
The trial results should allow the company to ask the FDA for approval of its vaccine in younger children, just as Pfizer nears a crucial decision for its shot in 5- to 11-year olds.
By Jonathan Gardner • Oct. 25, 2021 -
Novartis hits another setback in plan to repurpose rare disease drug in lung cancer
Canakinumab, which is approved as Ilaris, didn't slow progression or improve survival when used as a lung cancer treatment. Novartis still hopes it might work alongside surgery.
By Ned Pagliarulo • Updated Nov. 8, 2021 -
Roche's refillable eye implant becomes Eylea's latest threat
The FDA has approved Susvimo, a device that continuously administers a version of Roche's Lucentis over several months. It could challenge Regeneron's top-selling drug.
By Ben Fidler • Updated Oct. 25, 2021 -
What to watch at the FDA's high-stakes meeting on COVID-19 vaccines for kids
Documents released by the FDA Friday indicate agency staff are supportive of Pfizer's data, setting up an advisory panel meeting Tuesday that could open the door for an authorization in young children.
By Ben Fidler , Ned Pagliarulo • Updated Oct. 24, 2021 -
CDC panel levels playing field for new Merck, Pfizer pneumonia vaccines
New guidance for the rival shots didn't favor Pfizer's, as analysts had expected, giving Merck a better chance to gain ground in one of the most lucrative market opportunities for vaccines.
By Kristin Jensen • Oct. 21, 2021 -
Pfizer, in a first, shows booster shot strengthens COVID-19 protection in large study
A third dose was 96% effective in preventing COVID-19 compared to a placebo in a Phase 3 trial of previously vaccinated adults. Missing details, however, leave some questions unanswered.
By Ben Fidler • Oct. 21, 2021 -
Boehringer Ingelheim takes next step in development of cystic fibrosis gene therapy
Drugs from Vertex can effectively treat the lung disease in as much as 90% of patients. Gene therapy could be a solution for the remaining 10%, but the path forward is challenging.
By Shoshana Dubnow • Oct. 19, 2021 -
J&J foresees end to not-for-profit sales of coronavirus vaccine
The drugmaker plans to switch over to a commercial business model late next year or early in 2023, said Jennifer Taubert, head of J&J's pharma division.
By Ned Pagliarulo • Oct. 19, 2021 -
Esperion lays off nearly half its workforce as heart drug sales disappoint
The company hopes a "streamlined" sales force can turn around a drug launch that's failed to meet expectations amid tough competition from rival medicines.
By Jonathan Gardner • Oct. 18, 2021 -
Sponsored by Vetter Pharma
Emerging therapeutic oligonucleotides – analytical challenges accepted
A relatively new class of parenteral drug products on the market - therapeutic oligonucleotides – poses new challenges to the pharmaceutical manufacturing process.
By Alexandra H. Heussner, Ph. D., Laboratory Manager ASL, and Melanie Zerulla-Wernitz, Ph. D., Head of ASL, Development Service, Vetter Pharma-Fertigung GmbH & Co. KG • Oct. 18, 2021 -
FDA panel endorses second shot for adults who received J&J vaccine
Agency advisers unanimously supported offering a second dose of J&J's coronavirus vaccine to adults who previously received it, though guidance could change as regulators evaluate mixing boosters.
By Ben Fidler • Updated Oct. 15, 2021 -
AstraZeneca immunotherapy combo extends survival in liver cancer trial
The results are a rare positive result for AstraZeneca's experimental drug tremelimumab, which has come up short in a handful of other studies and cancer types.
By Ned Pagliarulo • Oct. 15, 2021 -
Merck advantage grows as FDA approves Keytruda for first-line cervical cancer
The company's immunotherapy is the only drug of its type cleared for advanced cervical cancer. Others are being tested, however.
By Ned Pagliarulo • Oct. 14, 2021 -
NIH study finds mixing COVID-19 boosters increases immune response
Results suggested Pfizer's and Moderna's vaccines may serve as a more potent booster for those who initially received Johnson & Johnson's shot, although data are limited and preliminary.
By Shoshana Dubnow • Oct. 13, 2021 -
Lilly drug cleared by FDA for wider use in breast cancer
Verzenio now has an expanded approval for treatment of a common form of early cancer, although the label granted by FDA places some limits on use.
By Kristin Jensen • Oct. 13, 2021 -
AstraZeneca builds case for long-acting COVID-19 drug, but is it too late?
The British drugmaker could soon become the first with both a marketed vaccine and treatment for COVID-19, a notable achievement. Yet competition has blunted the potential impact of each of them.
By Ben Fidler • Oct. 12, 2021 -
Adamas, Flexion sell for $825M combined as biotech's dealmaking pace picks up
After lagging for months, M&A has accelerated over the past five weeks. The latest evidence comes from two deals based largely on future drug sales.
By Jonathan Gardner • Oct. 11, 2021 -
Merck, Ridgeback seek US clearance of first oral COVID-19 drug
The two partners have officially filed for emergency authorization of their antiviral pill. It's not yet clear whether vaccine recipients would be eligible for treatment, however.
By Ben Fidler • Oct. 11, 2021 -
Pfizer officially seeks FDA clearance for coronavirus vaccine in kids
The companies' application starts a pressure-packed FDA review that could open up COVID-19 shots for tens of million Americans between the ages of 5 and 11.
By Shoshana Dubnow • Oct. 7, 2021