Strategy

Bristol Appoints AstraZeneca’s Massacesi As Next CMO

 

Chief Medical Officer Samit Hirawat will step down to pursue new career opportunities, the company said.

Deal Watch: Novartis Hopes To Ace Inflammatory Disease With Matchpoint Tie-Up

 

Plus deals involving Lilly/Gate Bioscience, Concentra/iTeos, Nicox/Kowa, Ajax/Schrodinger, I-Mab/Bridge Health, Otsuka/Cantargia, JCR/Acumen and more.

Viking Rapidly Advancing Oral And Injectable VK2735 For Obesity

 
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In its Q2 update, Viking reported that Phase III trials of subcutaneous VK2735 are under way, and that it expects Phase II data for an oral formulation before year’s end.

AZ Poised To Bring Self-Administered C5 Inhibitor To Market

 

Gefurulimab will give AstraZeneca a new option to compete against Argenx’s Vyvgart Hytrulo, which is available subcutaneously.


Roche Keen To Cut Out The Middle Men On US Pricing

 
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The Swiss giant has been talking to the US government about selling medicines directly to patients.

Leo Looks To Grow In US After Hand Eczema Cream Approval

 
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The Danish medical dermatology specialist doubles boosts its sales force ahead of the launch of Anzupgo.

Gateway To Africa: Natco Bids For 35.75% Of Adcock Ingram

 

Natco to buy out Adcock Ingram’s minority shareholders in what’s possibly its biggest M&A investment, opening up substantial opportunities in South Africa and the region. If the offer goes through, it will result in the delisting of Adcock, with Bidvest and Natco co-owning the firm.

Roche, Following Sarepta, Pauses Elevidys Shipments In Certain Countries

 
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Roche paused shipments of the Duchenne muscular dystrophy gene therapy in countries that reference US FDA approval of Elevidys after the agency asked Sarepta to pause US shipments; it remains available in Japan and Brazil.


Abivax Over The Moon As Obefazimod Storms Phase III

 
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Stock shoots up over 460% on positive results in two ulcerative colitis trials of the oral first-in-class candidate.

Scrip M&A Podcast: Is Biopharma M&A In A Holding Pattern Or A ‘New Normal’

 
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Scrip discusses the latest M&A activity and trends with CEO Shawn Titcomb of Allele Capital and Cheryl Reicin, a partner focused on international life sciences activity at Mintz.

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.

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.

After Gilead Deal, Hookipa Hangs Up Its Hat

 
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The Austrian firm is delisting from the NASDAQ and closing down.

Genentech Gets Columvi Complete Response Following ODAC’s No

 
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Seeking to move Columvi into second-line DLBCL, Genentech got an FDA letter saying the Phase III STARGLO study’s benefits may have been driven by results in Asian enrollees.

Novartis Chief Warns Of Fewer Launches And Drug Withdrawals In Europe

 
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Reimbursement rules are disincentivizing innovation, according to Vas Narasimhan.


AI-First, Big Pharma, Chinese Firms In Race - What’s Ahead For PRMT5 Inhibitors

 
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As AI-driven firms including Insilico, big pharmas J&J, Amgen, GSK and AstraZeneca and Chinese and Indian firms like BeOne and Dr. Reddy’s advance PRMT5 inhibitor candidates, what’s driving interest, what could lead to the first global approval and what are the challenges ahead?

Novartis Upbeat Even With Entresto Expiry Looming

 
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Swiss major confident that new oncology drugs will fill revenue gap.

Sarepta Restructures, Cuts 500 Jobs As Elevidys-Related Deaths Impact Sales

 
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After a second quarter of declining Elevidys sales following two deaths of DMD patients treated with the gene therapy, Sarepta is cutting costs to fund remaining programs and meet debt requirements.

Deal Watch: Debiopharm Takes On Precision Oncology Drug From Repare Collab

 

Plus deals involving Novartis/Sironax, Neuraxpharm/Dizlin, Recursion/RallyBio, MaaT/Clinigen, Future Pak/Theratechnologies, BerGenBio/Oncoinvent, Xoma/Turnstone and more.