Reviva Pharmaceuticals Holdings Inc. may be headed back to the clinic for another phase III study of brilaroxazine in treating schizophrenia. The U.S. FDA recommended the second study for the serotonin-dopamine and neuroinflammatory signaling modulator after a pre-NDA meeting in order to net more efficacy results and expand the safety dataset. If it has the financing, Reviva said it would begin the second study in the first half of the new year. Reviva’s stock (NASDAQ: RVPH) had been chopped nearly in half at midday, with shares down 47% to 31 cents each. 

Novo’s oral Wegovy wins FDA nod for obesity

Novo Nordisk A/S said the U.S. FDA approved a once-daily Wegovy (semaglutide) pill, the first oral GLP-1 medicine for obesity. The treatment is used with a reduced calorie diet and increased physical activity for adults with obesity, or with overweight who also have weight-related medical problems. It’s also cleared to reduce the risk of major adverse cardiovascular events. The go-ahead is based on the results from Bagsvaerd, Denmark-based Novo’s phase III Oasis 4 trial, a 64-week study that included 307 adults with obesity or overweight with one or more weight-related comorbidities, and without diabetes.

Shionogi nabs revenue-generating ALS drugs with $2.5B Tanabe pact

Shionogi & Co. Ltd. will acquire global rights to U.S. FDA approved amyotrophic lateral sclerosis therapy edaravone through a $2.5 billion acquisition deal with Tanabe Pharma Corp. Under the terms, Tanabe will form a new entity harboring both oral and intravenous (I.V.) infusion formulations of edaravone that are marketed in the U.S. as Radicava ORS (oral suspension) and I.V. Radicava.  Shionogi intends to purchase 100% of the newco’s shares on or after April 1, 2026. The transaction is expected to bolster Osaka, Japan-headquartered Shionogi’s rare disease portfolio, which includes ongoing programs for fragile X syndrome, Jordan’s syndrome and Pompe disease, according to Shionogi Inc. President and CEO Nathan McCutcheon.  

Feds break up alleged stock manipulation ring targeting biopharma

Six individuals, including an investment banker, face multiple federal charges stemming from an alleged $41 million insider-trading scheme, plus stock manipulation schemes involving biopharma companies. “As alleged, the defendants engaged in insider trading and market manipulation on a massive scale — using stolen information, falsified data and fake press releases to mislead investors and enrich themselves,” said Senior Counsel Philip Lamparello of the U.S. Attorney’s Office for the District of New Jersey.

China approves Abbisko/Merck’s CSF-1R inhibitor pimicotinib

Abbisko Therapeutics Co. Ltd. and its partner Merck KGaA got an early Christmas present from China’s National Medical Products Administration with the approval of pimicotinib (ABSK-021), the first domestically developed systemic therapy for tenosynovial giant cell tumor (TGCT). The approved indication is for treatment of adults with symptomatic TGCT for which surgical resection will potentially cause functional limitation or relatively severe morbidity.  

US Senate ends 2025 with no gift for kids with cancer

After being unanimously passed by the U.S. House Dec. 1, the bipartisan Mikaela Naylon Give Kids a Chance Act seemed to be headed for sure passage in the Senate before it adjourned late last week. But then a Grinch stole Christmas from children with cancer and their families. At least, that’s how the bill’s sponsor, Sen. Markwayne Mullin, R-Okla., characterized Sen. Bernie Sanders’, I-Vt., objection to unanimous consent for the Senate to vote on the bill, which includes reauthorizing the rare pediatric disease priority review voucher, advancing critical cancer research for kids and ensuring access to critical treatments. Sanders’ objection effectively killed the bill in the Senate for this year.

Hemophilia trial death with Pfizer’s Hypavzi under scrutiny

In a letter to the hemophilia community, Pfizer Inc. reported a death due to cerebellar infarction and subsequent cerebral hemorrhage in a long-term extension trial participant taking the New York-based company’s tissue factor pathway inhibitor antagonist Hympavzi (marstacimab). Approved by the U.S. FDA in October 2024 and by the EMA the following month, once-weekly subcutaneously-delivered Hympavzi aims to prevent or reduce bleeding in those 12 and older with hemophilia A or B. It was specifically approved for hemophilia A patients without factor VIII inhibitors and for hemophilia B patients without factor IX inhibitors.

Big pharma taps fast Asia innovation in search of next Keytruda 

Speed and innovation from Asia Pacific’s biotechnology sector had big pharma scouring the region for the next oncology heir to Keytruda (pembrolizumab), Merck & Co. Inc.’s reigning blockbuster cancer drug. Keytruda, a PD-1 inhibiting monoclonal antibody, has become akin to a Swiss army knife of immuno-oncology, winning more than 40 indications across nearly 20 cancer types since the first U.S. FDA approval in 2014. Its key patents, however, are slated to expire starting in 2028. Keenly understood by industry, the search is ongoing for next-generation monoclonal antibodies, specifically bispecifics and antibody-drug conjugates, to lead the next era of oncology. 

Vaccines: From the toast of the town to being in the crosshairs

BioWorld’s 2022 end-of-year highlights included a toast to the future – of universal vaccines. Even before SARS-CoV-2 vaccines were developed in record time and saved countless lives during the COVID-19 pandemic, vaccines were a rare bright spot in the fight against infectious diseases. Bacteria are becoming multidrug resistant far faster than new classes of antibiotics are being developed, viral spillover events and vector ranges are increasing, and climate change is helping bacteria and fungi alike breach human thermal protections against infections.

Vaccine policy and the terrible, horrible, no good, very bad year

Driven by a deeply antiscientific political agenda, the current U.S. government is not just sabotaging some of the most groundbreaking technology that has been developed in the past decades. It is also destroying the country’s past successes, such as measles elimination and the reduction of hepatitis B infections in infants to near zero.

Also in the news

Aktis, Altamira, Alzinova, Assembly, Astrazeneca, Atea, Boehringer Ingelheim, Coregen, Cytokinetics, Daiichi Sankyo, Entera, Etiome, Gensight, Geovax, Gilead, Hansa, Humacyte, Huonslab, Immutep, Imviva, Incyte, Ipsen, Kalvista, Neurosense, Novakand, Promontory, PTC, Rectify, Repertoire Immune Medicines, Rheumagen, Roche, Savara, Simcere Zaiming, Sinaptica, SVF Vaccines, Transcode, Viridian, Windward