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Pharma News

FDA backs pharmacist prescribing of Paxlovid for COVID
FDA backs pharmacist prescribing of Paxlovid for COVID
Some patients with COVID-19 will be able to get easier access to Pfizer’s oral antiviral therapy Paxlovid, after the FDA ruled that pharmacists would be able to prescribe the drug. ...
Merck in “advanced talks” for $40bn Seagen bid; report
Merck in “advanced talks” for $40bn Seagen bid; report

The rumour that Merck & Co is preparing to make a sizeable offer to buy cancer specialist Seagen won’t go away.

Analyst: Value of Accelerated Approvals Exceeds Minimal Medicaid Costs
Analyst: Value of Accelerated Approvals Exceeds Minimal Medicaid Costs
The U.S. Food and Drug Administration’s accelerated approval process has faced intense scrutiny over the past several months, with concerns ranging from a failure of drugs to live up to early cli...
FDA Grants Priority Review to Roche’s Lunsumio for Follicular Lymphoma
FDA Grants Priority Review to Roche’s Lunsumio for Follicular Lymphoma
The FDA has accepted Roche’s Biologics License Application (BLA) for Lunsumio (mosunetuzumab) and has granted the drug a priority review for treatment of adult patients with relapsed or refractor...
Eisai/Biogen could get FDA verdict on new Alzheimer’s drug by 6 Jan
Eisai/Biogen could get FDA verdict on new Alzheimer’s drug by 6 Jan
The FDA has started an accelerated review of Eisai and Biogen’s a new amyloid-targeting antibody lecanemab for Alzheimer’s disease, with a 6 January deadline that keep them ahead of closest ri...
The US approved the ecstasy test for PTSD
The US approved the ecstasy test for PTSD
The Interdisciplinary Association for Psychedelic Research reports that ecstasy (3,4-methyl​enedioxy​methamphetamine, MDMA) will be used for patients suffering from post-traumatic stress diso...
FDA halts tests of Sanofi drug, acquired in $3.7B buyout, due to side effects
FDA halts tests of Sanofi drug, acquired in $3.7B buyout, due to side effects
The Food and Drug Administration has required Sanofi to stop treating some patients in Phase 3 trials of an experimental multiple sclerosis drug and pause enrollment in the studies in an effort to ...
FDA Accepts Aflibercept sBLA for Treatment of Diabetic Retinopathy
FDA Accepts Aflibercept sBLA for Treatment of Diabetic Retinopathy
If approved, the 16-week dosing regimen could offer certain individuals a potentially longer treatment interval and physicians with greater flexibility to individualize treatment. ...
AstraZeneca Bolsters Blood Cancer Pipeline with $1.27B TeneoTwo Takeover
AstraZeneca Bolsters Blood Cancer Pipeline with $1.27B TeneoTwo Takeover
AstraZeneca is strengthening its oncology pipeline with the acquisition of TeneoTwo, which has an ongoing Phase I trial in relapsed and refractory B-cell non-Hodgkin lymphoma, in a deal valued at u...
FDA Recommends Modified COVID-19 Vaccine Boosters Adapted to Omicron BA.4 and BA.5 Subvariants
FDA Recommends Modified COVID-19 Vaccine Boosters Adapted to Omicron BA.4 and BA.5 Subvariants
The FDA recommended that COVID-19 vaccine manufacturers update their COVID-19 Vaccines with an Omicron BA.4/5 spike protein component to create a bivalent booster vaccine. ...
Sirana Pharma and Pfizer to work on treatment for brittle bone disease
Sirana Pharma and Pfizer to work on treatment for brittle bone disease
German biotech company Sirana Pharma GmbH has entered into a collaborative research agreement with Pfizer Inc. to investigate the potential identification and validation of a novel treatment concep...
After coeliac fail, 9 Meters plots phase 3 in short bowel syndrome
After coeliac fail, 9 Meters plots phase 3 in short bowel syndrome
Two weeks after reporting disappointing results for its lead coeliac disease therapy, 9 Meters Biopharma will draw some comfort from a mid-stage trial of its candidate for short bowel syndrome (SBS...
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