Pharma: Page 52
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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 -
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Brian Tucker / BioPharma Dive/BioPharma Dive
TrendlineTop 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 -
Permission granted by Vetter Pharma
Sponsored by Vetter PharmaEmerging 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 -
Michael Ciaglo via Getty Images
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 -
Lisa Maree Williams via Getty Images
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 -
Jacob Bell/BioPharma Dive
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 -
Jens Schlueter via Getty Images
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 -
Courtesy of Eli Lilly
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 -
Christopher Furlong via Getty Images
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 -
Elizabeth Regan/BioPharma Dive
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 -
Courtesy of Merck & Co.
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 -
Spencer Platt via Getty Images
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 -
Bristol Myers' top autoimmune drug prospect takes a hit in mid-stage trial
The failure of the pharma's TYK2 blocker in the first of two ulcerative colitis studies is a setback for a treatment that's expected to become a top-seller.
By Ben Fidler • Oct. 7, 2021 -
Mario Tama via Getty Images
J&J heats up RSV race with new vaccine data
The company's candidate is one of two to enter late-stage testing for a respiratory virus that causes hundreds of thousands of hospitalizations a year.
By Jonathan Gardner • Oct. 4, 2021 -
Gilead wins approval of CAR-T therapy in adult leukemia
Tecartus, Gilead's second cell therapy on the market, is the first CAR-T treatment to be cleared for use in people older than 18 with ALL.
By Ned Pagliarulo • Updated Oct. 4, 2021 -
Warren Little via Getty Images
GSK, Merck KGaA end cancer drug partnership after study results disappoint
Bintrafusp alfa was highlighted by GSK as a potential blockbuster drug as recently as January. Negative findings in two trials, however, led the companies to unwind their research collaboration.
By Ned Pagliarulo • Oct. 1, 2021 -
Courtesy of Merck & Co.
Merck says antiviral pill effective against COVID-19, lifting hopes for first oral drug
The drugmaker, along with partner Ridgeback Biotherapeutics, plan to ask the FDA for emergency authorization "as soon as possible" following results so striking that testing was stopped early.
By Ben Fidler • Oct. 1, 2021 -
Courtesy of Sanofi Pasteur
Sanofi claims positive early data for mRNA COVID shot, but pivots to flu instead
With Pfizer's and Moderna's vaccines broadly used, Sanofi says it will focus on its protein-based coronavirus candidate. The French pharma sees more promise for its mRNA work in influenza.
By Jonathan Gardner • Sept. 28, 2021 -
Eisai, Biogen to test FDA by asking for approval of second Alzheimer's drug
The Japanese pharma and Biogen partner is filing an application for an accelerated OK of lecanemab, which works similarly to the companies' controversially cleared Aduhelm.
By Ned Pagliarulo • Updated Sept. 28, 2021 -
FDA lifts hold on GeneTx, Ultragenyx study of Angelman therapy
The hold, which was put in place during the fourth quarter last year, came after five patients in an early trial experienced muscle weakness following treatment.
By Shoshana Dubnow • Sept. 27, 2021 -
Erik S. Lesser via Getty Images
As FDA scrutinizes immunotherapy approvals, Merck says Keytruda extends survival in liver cancer trial
Phase 3 results showed Merck's drug improved overall survival versus placebo, which should lessen pressure for a market withdrawal in the indication.
By Jonathan Gardner • Sept. 27, 2021 -
iStock.com/PeopleImages
Sponsored by SGSCharged aerosol detection: Chromatographer's magical tool to unravel the invisible in biologics
The discovery and development of next generation therapeutics will drive the availability and use of Biologics to meet the unmet medical needs, never imagined before.
By Yena Patel, Sahil Shah and Bart Byczynski • Sept. 27, 2021 -
Insurers sue Merck for 'monopolistic scheme' to delay generics of blockbuster cholesterol drug
The suits allege an agreement between Merck and a generic manufacturer kept low-cost versions of the drugmaker's widely used Zetia off the market for years.
By Samantha Liss • Sept. 24, 2021 -
Lisa Maree Williams via Getty Images
AstraZeneca strikes deal with university spinoff to turn RNA into drugs
The British drugmaker is investing in VaxEquity, a biotech founded last year to explore a twist on the mRNA technology that Moderna and BioNTech have made famous.
By Ned Pagliarulo • Sept. 23, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Chinese drugmaker Clover says vaccine prevents COVID-19 in large trial
Positive results from Clover's Phase 3 study could mean another coronavirus vaccine option for the many countries still grappling with short supplies.
By Jonathan Gardner • Sept. 22, 2021
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