The U.S. FDA granted approval of Verona Pharma plc’s ensifentrine on its PDUFA date of June 26, giving the chronic obstructive pulmonary disease (COPD) community its first new mechanistic option in a decade. The drug, branded Ohtuvayre, is also the first inhaled nonsteroidal therapy to treat a respiratory disease that combines both a bronchodilator and anti-inflammatory mechanism into one molecule. It is indicated for the maintenance treatment of COPD, which Verona said allows for broad use. Ohtuvayre is a dual action inhibitor of phosphodiesterase 3 and 4 that the company priced at $2,950 per month.

Daiichi, Merck’s HER3-DXd gets CRL for lung cancer

Partners Daiichi Sankyo Co. Ltd. and Merck & Co. Inc. received a complete response letter (CRL) from the U.S. FDA for their first-in-class HER3-directed antibody-drug conjugate HER3-DXd (patritumab deruxtecan) to treat patients with locally advanced or metastatic EGFR-mutated non-small-cell lung cancer. The CRL did not identify issues with efficacy or safety, but is due to findings during an inspection of a third-party manufacturing facility. Ken Takeshita, Daiichi’s global head of R&D, said the companies will work with the agency and manufacturer “to address the feedback as quickly as possible.” Daiichi and Merck were seeking accelerated approval.

Calcimedica phase IIb succeeds, though stock swoons

Positive top-line results from Calcimedica Inc.’s placebo-controlled phase IIb of Auxora in acute pancreatitis couldn’t support the stock at midday. The small molecule hit the study’s primary endpoint, the median time it took to tolerate solid food, as patients who received Auxora had a statistically significant dose response compared to those who received placebo. Auxora also showed a statistically significant dose response in reducing severe organ failure. The clinical trial produced a 100% reduction of hospital stays that were longer than 21 days. Still, Calcimedica’s stock (NASDAQ:CALC) was suffering at midday, as shares were down 31% to $3.20 each.

Supremes reject Purdue plan, uphold right to jury trial in SEC cases

In a 5-4 decision, the U.S. Supreme Court today scuttled a Purdue Pharma LP’s bankruptcy plan that would have discharged any claims against the Sackler family, which owned and controlled the company that made billions of dollars from its sales of Oxycontin (oxycodone). The majority of the court held that the U.S. bankruptcy code doesn’t authorize the release and injunction of claims against a nondebtor without the consent of claimants. Calling the majority’s decision wrong, the four dissenting justices said it rewrites the bankruptcy code “and restricts the long-established authority of bankruptcy courts to fashion fair and equitable relief for mass-tort victims.” They also warned that the decision will be “devastating for more than 100,000 opioid victims and their families.” In a separate case, the court clipped the SEC when it upheld the right to a jury trial when the commission seeks civil penalties for securities fraud.

Obesity drug competition expands

Multiple companies presented data on their obesity drugs at the American Diabetes Association 84th Scientific Sessions, including stalwarts, Novo Nordisk’s semaglutide and Eli Lilly’s tirzepatide, and up and comers, Altimmune's pemvidutide and Fujian Shengdi Pharmaceutical’s HRS-9531. With all the upcoming competition, companies will need to find a way to differentiate themselves.

SK Bioscience to acquire Klocke‘s CDMO in cross-holding M&A

South Korea’s SK Bioscience Co. Ltd. has entered a cross-shareholding acquisition deal with Germany’s Klocke Pharma-Service GmbH to acquire its contract development and manufacturing organization (CDMO), IDT Biologika Corp. SK Bioscience will acquire IDT Biologika for about ₩339 billion (US$244.47 million) through a wholly owned subsidiary established in Germany and become its largest stakeholder.

US FDA disinclined to grant waivers for clinical trial diversity plans

The U.S. FDA has reissued a 2022 draft guidance for clinical trial diversity at the behest of legislation from Congress, ballooning the previous nine-page draft to a full 23 pages. One of the provisions of the new draft is the statement that the agency “does not intend to waive” the requirement for a diversity plan even if the condition under study is “relatively homogenous” for race, ethnicity, sex or age group, a signal that sponsors should have a diversity plan at the ready regardless of the nature of the disease under study.

New techniques open the way for large-scale programmable genome editing

New single-step genome editing techniques that enable the insertion, inversion or deletion of long DNA sequences at specified genome positions have been demonstrated in bacteria. The advance opens the door to the development of programmable methods for rearranging DNA, using recombinase enzymes guided by RNA. The two different approaches to using insertion sequences – some of the simplest and most compact mobile genetic elements – are described in two papers published in Nature and Nature Communications.

Also in the news

Actinogen, Agile, Allakos, Alligator, Allurion, Anima, Annexon, Antengene, Argenx, Arrowhead, Astrazeneca, Bavarian Nordic, Brainstorm Cell, Camurus, CN Bio, CNS, Diamedica, Eli Lilly, Encell, Huadong Medicine, Hyundai, Immuno Cure, Insud, Intellia, Iomx, Lyell, Neurobo, Neurona, Openai, Oryzon, Parallel Biosystems, Savara, Sensorion, Simcere Zaiming, Star, Taysha Gene Therapies, TFF, Tourmaline, Valneva, Vir