Pharma
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BioNTech, WHO hatch plan to bring mRNA vaccines to Africa
Responding to criticism, the German biotech plans to develop a malaria shot and build manufacturing infrastructure on the continent.
By Jonathan Gardner • July 26, 2021 -
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Drug distributors, J&J agree to pay $26B in major opioid settlement with states
The long-negotiated deal could resolve the vast majority of lawsuits against the companies for their alleged role in contributing to the opioid epidemic.
By Kristin Jensen • July 22, 2021 -
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TrendlineThe expanding world of RNA therapies
Vaccines from BioNTech and Moderna proved the power of messenger RNA in medicine. A growing field of RNA-targeting therapies is advancing alongside them.
By BioPharma Dive staff -
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Pfizer, BioNTech ink vaccine supply deal for Africa in step toward addressing criticism
The companies aim to deliver 100 million doses per year to 55 African countries in an effort to shrink the wide gap between high- and lower-income countries in coronavirus vaccinations.
By Jonathan Gardner • July 21, 2021 -
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J&J predicts faster coronavirus vaccine sales amid debate over boosters
The pharmaceutical company expects $2.5 billion in sales from its shot this year, despite concerns over protection against variants and significant manufacturing setbacks.
By Ned Pagliarulo • July 21, 2021 -
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Merck to take on Pfizer with FDA OK of next-gen pneumonia vaccine
Approval of Merck's shot sets the stage for the two large pharmas to compete for market share with new pneumococcal vaccines that are meant to improve on older versions.
By Jonathan Gardner • July 19, 2021 -
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FDA advisers push back on FibroGen anemia drug
Safety worries led to a near-unanimous vote against roxadustat in kidney disease patients, dimming the approval chances of what would be the first pill to boost red blood cells.
By Jonathan Gardner • July 16, 2021 -
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Merck details an immunotherapy 'milestone' in early breast cancer
Three months after a rare FDA rejection, Merck has data showing Keytruda can slow the return of triple-negative breast cancer but not, as of yet, proving whether the drug extends lives.
By Ben Fidler • July 15, 2021 -
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AstraZeneca deal for Alexion to close soon as UK regulator clears acquisition
The go-ahead from British regulators was the last hurdle standing in the way of the two companies wrapping up their $39 billion deal announced last year.
By Kristin Jensen • July 14, 2021 -
Lilly wagers up to $1B on a biotech's plan for a new type of insulin
Rival Novo Nordisk has jumped ahead in developing an injectable drug that responds to changes in blood sugar. An acquisition of Protomer Therapeutics could help Lilly close the gap.
By Jonathan Gardner • July 14, 2021 -
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FDA flags rare side effect in new warning on J&J's coronavirus vaccine
The agency said the benefits of vaccination with J&J's shot still "clearly outweigh" the risks, which now include very rare cases of an immune-driven condition known as Guillain-Barré.
By Jonathan Gardner • July 12, 2021 -
Permission granted by Biogen
Alzheimer's Association, insurers press Medicare for coverage rules on Aduhelm
Days after the FDA narrowed the target population for Biogen's drug, the patient advocacy group said it's urging Medicare to adopt a nationwide policy. Payers are seeking guidance, too.
By Jonathan Gardner • UPDATED: July 12, 2021 at 5:20 p.m. -
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Healthcare mergers, 'pay for delay' deals get added scrutiny under Biden order
The executive order issued Friday calls on regulators to "enforce the antitrust laws vigorously" and to ban the controversial agreements that can slow the arrival of generic drugs.
By Samantha Liss • July 09, 2021 -
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GSK returns to brain drugs with major biotech deal
The pharmaceutical giant best known for its work in cancer, HIV and respiratory illnesses is now paying at least $700 million to get its hands on two experimental drugs from Alector.
By Jacob Bell • July 02, 2021 -
Courtesy of Sanofi
Sanofi dives deeper into mRNA in search for next-generation vaccines
The French pharma plans to invest nearly $500 million annually on a new "center of excellence" meant to speed the development of mRNA vaccines, which have come of age during the pandemic.
By Jonathan Gardner • UPDATED: June 29, 2021 at 2:10 p.m. -
Courtesy of Eli Lilly
Coronavirus variants deal another blow to Lilly's COVID-19 drug business
The U.S. government has stopped distributing the drugmaker's COVID-19 antibody combination nationwide, just two months after the FDA pulled its other antibody treatment from the market.
By Ben Fidler • June 28, 2021 -
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Sponsored by IQVIAReveal the "hidden clinical leaders" who drive HCP network adoption
Optimizing your insights into HCP/thought leader networks is critical for promoting new treatments.
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With Alzheimer's drugs in focus, Bristol Myers rejoins the hunt
The pharmaceutical giant is spending $80 million for an exclusive license to an experimental drug developed by Prothena.
By Jacob Bell • June 24, 2021 -
Reversing course, Lilly to seek fast approval for experimental Alzheimer's drug
The drugmaker said it will file an application with the FDA later this year for accelerated approval of donanemab, a change of plans that comes weeks after the FDA's controversial clearance of Biogen's Aduhelm.
By Ned Pagliarulo • UPDATED: June 24, 2021 at 10:08 a.m. -
Courtesy of GSK Flickr page
GSK outlines ambitious 10-year plan, but hits investors' near-term outlook
Under pressure from activist investors, the British drugmaker set lofty sales targets for a "new GSK" after a planned exit from consumer health. But shareholders will first face a dividend cut.
By Jonathan Gardner • June 23, 2021 -
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Merck says Keytruda extends survival in cervical cancer study
Results from a Phase 3 study could help Merck secure a full approval for use of Keytruda in the tumor type, potentially extending the therapy's edge over rival therapies.
By Jonathan Gardner • June 22, 2021 -
Novartis
Long-term Zolgensma data backs up gene therapy's use in youngest patients
With more and more states screening for SMA at birth, the study results are important for assessing Zolgensma's benefits when given very early on.
By Jonathan Gardner • June 21, 2021 -
Permission granted by Bristol-Myers Squibb
Bristol Myers partners with Eisai in $650M deal for targeted cancer antibody
The U.S. drugmaker is the latest to invest large sums of money in antibody-drug conjugates, following recent deals by Gilead, Merck and AstraZeneca.
By Jonathan Gardner • June 18, 2021 -
Anthem joins insurer-backed generics effort CivicaScript
The subsidiary of hospital-owned nonprofit CivicaRx plans to make six to 10 common generic drugs that don't have enough competition to drive down cost.
By Rebecca Pifer • June 16, 2021 -
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Former FDA chief Hahn joins venture firm that launched Moderna
Hahn's appointment as chief medical officer of Flagship Pioneering is another example of FDA officials joining industry after their government service. Hahn's predecessor, Scott Gottlieb, sits on Pfizer's board of directors.
By Jonathan Gardner • June 15, 2021 -
Permission granted by Emergent Biosolutions
Sponsored by Emergent BiosolutionsLyophilized products are on the rise: Here's what you need to know
To extend the shelf life and improve stability of biopharmaceuticals, a freeze-drying process—and a partner—can help.
By Kate Silver • June 14, 2021
