Falling sales are not typically welcomed by investors, while good revenue growth is prized. The first-quarter earnings season provided exceptions to this rule, and then there was Amgen.

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.

Recent moves in the industry include new chief scientific officer at Wave Life Sciences, while Alliance Pharma gets a new CEO.

Plus transactions involving Sanofi/Fulcrum, Reneo/OnKure, Lilly/Mitsubishi Tanabe, Lantern/Oregon, Zydus/Eiger and more.

Next Generation Gene Therapeutics is fast-tracking clinical trials in the US for its gene therapy candidates for Bietti's crystalline dystrophy and classic phenylketonuria, supported by China data, the Chinese venture's CEO tells Scrip in an interview.

Ajax Therapeutics plans to take its type II JAK2 inhibitor into the clinic during the second half of 2024 with the aim of modifying disease in a way that first-generation type I inhibitors do not. 

Combination mechanisms, less frequent dosing and scalability are the goals of the collaboration.

Aiming to help create China’s first original treatment for under-researched rare diseases, the Hope for Rare Foundation is racing against a funding crunch to support translational research in China, its co-founder and secretary-general tells Scrip in an interview.

The industry’s top-selling drugs generate billions in revenues each year. Scrip analyzed data on nearly 200 blockbuster drugs to see which are forecast to make the most at peak and over a 14-year time horizon.

Indian firms accounted for over 50% of prescription volumes in five of the top 10 therapy areas in the US in 2022, as also 15% of the volume share of biosimilars, delivering savings and widening patient coverage a study by IQVIA said, while also highlighting supply chain risks that need attention.

Pfizer/BioNTech’s COVID-19 vaccine Comirnaty toppled after recording the highest ever annual sales for a pharmaceutical in 2022, while Novo Nordisk’s Ozempic climbed rapidly. But Merck & Co’s immuno-oncology blockbuster Keytruda was secure in the number one spot in 2023 as COVID-19 receded.

The highs of the COVID-19 era, and the lows that supplanted it, are beginning to fade.

The US presidential election in November could mean IRA expansion from a Biden win, but a Trump victory also brings uncertainty.

Falling sales are not typically welcomed by investors, while good revenue growth is prized. The first-quarter earnings season provided exceptions to this rule, and then there was Amgen.

Phase III results suggest Bayer’s elinzanetant has a safety and efficacy advantage over its Astellas rival in reducing hot flashes, but investors are still not convinced the drug will be a blockbuster.

The US vaccines maker has been under the cosh from a very vocal investor who was unhappy with the performance of commercially disappointing COVID-19 shot Nuvaxovid and strategy in general. However, a recent pact with Sanofi worth up to $1.2bn has had a soothing effect.

In this week's podcast edition of Five Must-Know Things: the life of a blockbuster; blockbusters by indication; gene therapy struggles; sun shines on AstraZeneca and GSK; and Korean ventures look to Japan.

The San Diego biotech is also de-emphasizing three ongoing targeted cancer therapy candidates and giving itself the flexibility to focus on RAS- or KRAS-targeting approaches.

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.

Cipla is stepping into the oligonucleotides space, where it also hopes to help shape the regulatory environment. Action is also anticipated in ‘big, identified areas’ such as obesity that may see potential partnering opportunities with Eli Lilly, with which the Indian firm has an existing alliance for diabetes therapies.

Next Generation Gene Therapeutics is fast-tracking clinical trials in the US for its gene therapy candidates for Bietti's crystalline dystrophy and classic phenylketonuria, supported by China data, the Chinese venture's CEO tells Scrip in an interview.

Deputy director of the Bureau of Competition Rahul Rao discussed the agency’s thinking on recent pharma deals that it viewed as anti-competitive.

Development has ended for BIIB105 in ALS after it failed to clear a crucial biomarker and show clinical benefit. Also, Biogen opted not to advance ION582 for Angelman syndrome, so Ionis will go it alone.

The privately held biotech will bring J&J a pair of bispecific antibodies expected to target multiple pathologic pathways in atopic dermatitis and asthma.