Shares in Sierra Oncology Inc. (NASDAQ:SRRA) surged 38.4% by midday April 13 as Glaxosmithkline plc made a $55-per-share offer for the company, which values it at $1.9 billion. The offer represents a premium of about 39% on Sierra’s April 12 closing share price of $39.52 and a premium of about 63% over its volume-weighted average share price over the last 30 trading days.

Signed, sealed, drug delivery: Halozyme buys Antares for $960M

Halozyme Therapeutics Inc. is buying Antares Pharma Inc. for about $960 million. The deal brings Halozyme an autoinjector platform to complement its Enhanze drug delivery technology, which is designed to reduce hours-long treatments to minutes. Antares’ autoinjector platform is suitable for use with a range of medications, including the potential for conversion to both high-viscosity and high-volume autoinjector devices, according to Halozyme. Halozyme is also getting Antares’ recently U.S. FDA-approved oral testosterone replacement therapy, Tlando (testosterone undecanoate). Ewing, N.J.-based Antares got a massive boost from the news as shares (NASDAQ:ATRS) were trading 50% higher at midday, at about $5.57 each.

Biopharma deal values rise by 36% in Q1, while M&As are at lowest point

Although efforts focused on COVID-19 continue to fade and there are fewer collaborations than in previous years, the biopharma industry has recorded record value from mega-deals in the first quarter (Q1) of 2022, topping all recent years, as executives continue to opt against costly mergers and acquisitions.

AACR 2022: Viruses, vaccines, ventricular delivery help solid tumor CAR Ts

“We’re still a far cry from reproducible, durable benefits” with CAR T cells targeting solid tumors, Crystal Mackall told the audience at the 2022 annual meeting of the American Association for Cancer Research (AACR 2022). But “we’re beginning to see some signals.” At the meeting, Mackall’s team as well as others reported heartening early clinical data in tough indications. Meanwhile, papers in the April 13, 2022, issues of Nature and Science Translational Medicine, respectively, gave new research insights into how to make CAR T cells fit for solid tumors.

Big pharma CEOs lambast IP waiver and worry over US funding for COVID meds

Pharma CEOs have pushed back strongly against intellectual property (IP) waivers for COVID-19 vaccines and therapies, saying that pricing is not the reason why middle- and low-income countries have not received pharmaceutical countermeasures against the pandemic. Senior execs from Pfizer Inc., Eli Lilly and Co., and Roche Holding AG, also expressed concerns about the latest funding package from the U.S. government, which at $10 billion is less than half that originally requested by the White House.

Shionogi’s COVID treatment could disturb fetal development, impact regulatory approval

Shionogi & Co. Ltd.’s plans for S-217622 (ensitrelvir), its oral antiviral drug for COVID-19, to become the first domestically approved COVID-19 treatment have hit a snag. Animal studies showed the drug disturbed fetal development, according to media reports. But the Osaka, Japan-based company countered that the data were not new and would not impact its development plan for the drug. “Our filing data, which was submitted to the Pharmaceuticals and Medical Devices Agency on February 25th, 2022, included this information,” a Shionogi spokesperson told BioWorld. Still, Shionogi’s Japanese shares tumbled 11.14% to ¥6,611 ($52.72) at the end of trading on April 13, after falling as low as ¥6,252 earlier in the day, the biggest slump since March 2011.

Beigene’s zanubrutinib meets primary endpoints in phase III CLL trial

Beigene Ltd.’s Brukinsa (zanubrutinib) has met the primary endpoints in a phase III trial to treat patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma. Data showed that zanubrutinib is superior compared to ibrutinib in overall response rate, with a response rate of 80.4% vs. 72.9% (two-sided p=0.0264). “We understand that for people living with CLL and their families, relapse and treatment resistance are especially devastating. That's why we are encouraged by this final response analysis,” said Lai Wang, global head of research and development at Beigene.

CDR-Life secures $76M series A to back cancer immunotherapy programs

CDR-Life Inc. has closed a $76 million series A round to advance development of a new generation of cancer immunotherapies designed to treat solid tumors by targeting intracellular antigens that occur only in tumors, with the aim of increasing effectiveness while reducing off-target effects. The lead program, CDR-404, a T-cell engager directed at the tumor-associated antigen MAGE-A4 that is presented on the major histocompatibility (MHC) complex, will now be advanced to IND-enabling studies and through to clinical proof of concept.

Cimeio ‘points’ the way to safer cell therapy with $50M series A round

Versant Ventures is committing $50 million in series A funding to Cimeio Therapeutics Inc., which aims to bring new possibilities in terms of disease targeting and safety to bear on a wide range of cell therapy applications, including hematopoietic stem cell transplantation (HSCT) and adoptive cell transfer.

US FDA calls for diversity plans for drug, device trials

In its latest effort to increase clinical trial diversity, the U.S. FDA issued a draft guidance today focused on one aspect of diversity – improving enrollment of participants from underrepresented racial and ethnic populations. The guidance recommends that drug and device sponsors develop and submit a race and ethnicity diversity plan to the agency early in the clinical development process. “The U.S. population has become increasingly diverse, and ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health,” FDA Commissioner Robert Califf said in announcing the new guidance. “Going forward, achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities.”

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