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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 -
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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 -
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 -
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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 -
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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 -
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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 -
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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 -
Lisa Maree Williams via Getty Images
US buying 500M more doses of Pfizer coronavirus vaccine for donation to world
Under pressure to help other countries access vaccines, Biden is doubling his administration's planned donation to 1 billion doses, although delivery will extend through September of next year.
By Ned Pagliarulo • Sept. 22, 2021 -
Jon Cherry via Getty Images
Second dose of J&J's coronavirus vaccine increases protection, company says
Long-awaited results from a Phase 3 study run by J&J could support use of a booster dose, although the drugmaker has not officially applied for FDA clearance yet.
By Shoshana Dubnow • Sept. 21, 2021 -
Seagen, Genmab win speedy FDA approval for cervical cancer drug
Tivdak, a type of drug known as an antibody-drug conjugate, is the fourth approved medicine for Seagen and its third to reach market since December 2019.
By Jonathan Gardner • Sept. 21, 2021 -
Novartis pushes further into gene therapy for the eye with deal for Swiss startup
The large drugmaker has acquired Arctos Medical and its preclinical research into optogenetics, an area Novartis already showed interest in with its buyout of Vedere Bio last year.
By Ned Pagliarulo • Updated Sept. 23, 2021 -
Antonio Masiello via Getty Images
Pfizer says coronavirus vaccine is safe and spurs immune response in children
The results position Pfizer and BioNTech to seek clearance in children as young as 5 years old. But the companies haven't yet shared data on a rare heart inflammation associated with their shot that's a concern for regulators.
By Jonathan Gardner • Sept. 20, 2021 -
ESMO21: Mirati sets new KRAS bar, AstraZeneca's breast cancer data and Keytruda challengers line up
Mirati's KRAS-blocking drug looks to have an edge over Amgen's, while AstraZeneca and Daiichi reported impressive data for their drug Enhertu.
By Ned Pagliarulo • Updated Sept. 21, 2021 -
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Sponsored by IQVIAWhy 'hidden' thought leaders and their networks can make (or break) your launch
Finding the right thought leaders is not as simple as searching for KOLs or identifying high-volume prescribers.
By John Eichert, Senior Principal, Thought Leader Network CoE; Jennifer Millard, Vice President, Field Medical Affairs Deployment Services; and Bruce West, Senior Principal, Thought Leader Network CoE • Sept. 20, 2021 -
Takeda wins FDA approval for targeted lung cancer drug
Exkivity follows Johnson & Johnson's Rybrevant on the market for treating lung tumors harboring specific mutations in the EGFR gene. Unlike J&J's drug, however, Takeda's is given orally.
By Kristin Jensen • Sept. 16, 2021
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