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Replimune CRL Could Hold Warning For Accelerated Approvals

 

FDA issued a complete response letter to Replimune’s BLA for a novel oncolytic immunotherapy for melanoma in a surprise to management and investors.

Sanofi Doubles Down On Respiratory Vaccines With Vicebio Buy

 
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The French major is paying $1.15bn For the UK biotech and its bivalent candidate, VXB-241.

Chinese Biotechs Sweep ADC Plus PD-(L)1/VEGF Bispecific Combos Into Phase II

 

Chinese firms Junshi, Minghui and RemeGen rank among the world’s few players progressing antibody-drug conjugates combined with PD-(L)1/VEGF bispecific antibodies in Phase II trials for various cancers.

Pharma Gets A Compatriot At CDER With Tidmarsh Appointment To Top Spot

 

Drug manufacturers may find comfort in the appointment of former biotech CEO and entrepreneur George Tidmarsh to lead the FDA’s Center for Drug Evaluation and Research.

Business


Finance Watch: Sarepta’s Debt Woes Grow With Elevidys Shipment Pause

 
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Public Company Edition: Sarepta restructured after stopping shipments of its Elevidys for some patients to ease future debt pressures, but now it has stopped shipments to all patients. Also, Madrigal secured up to $500m in new debt, Cogent closed a $230m offering and other financings.

Avalyn Raises $100m Series D To Advance Inhaled Pulmonary Fibrosis Candidates

 
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Looking to improve on the efficacy and safety of Roche’s Esbriet and BI’s Ofev, Avalyn has inhalable formulations of those drugs in Phase IIb and Phase I, respectively.

AstraZeneca Pledges Big Investment In US Manufacturing Amid Tariff Threats

 

The drugmaker plans to build a large manufacturing center in Virginia as the centerpiece of an effort to invest $50bn in the US by 2030.

Replimune CRL Could Hold Warning For Accelerated Approvals

 

FDA issued a complete response letter to Replimune’s BLA for a novel oncolytic immunotherapy for melanoma in a surprise to management and investors.

Scrip Originals


Finance Watch: Sarepta’s Debt Woes Grow With Elevidys Shipment Pause

 
• By 

Public Company Edition: Sarepta restructured after stopping shipments of its Elevidys for some patients to ease future debt pressures, but now it has stopped shipments to all patients. Also, Madrigal secured up to $500m in new debt, Cogent closed a $230m offering and other financings.

Stock Watch: Q2 Sales Growth Sparks Diverging Reactions To J&J And Novartis

 
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With drug sector indexes underperforming the broad market in the first half of 2025, investors may have been anticipating tariff-related and other headwinds. But impending loss of exclusivity on key products may be provoking more anxiety at this point.

Pipeline Watch: Five Approvals And Twelve Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Executives On The Move: Five New CEOs Among This Week’s Changes

Recent moves in the industry include changes at the top at Ascentage Pharma, Inventiva and Brenig Therapeutics, plus five companies get new CFOs.