Biopharma M&A is on an uptick compared to the post-pandemic doldrums of the last two years. Analysts anticipate that the trend will continue in 2023 and into 2024 as companies attempt to beef up their portfolios.During second quarter earnings calls, many heavy-hitters—including Johnson & Johnson, Bristol Myers Squibb and Merck—expressed urgency in their quest for deals. With so many buyers in competition, sellers are finding offers that are more attractive. For example, Merck’s $10.8 billion proposal to acquire Prometheus in April came at a 75% premium. In July, Biogen’s $7.3 billion deal for Reata represented a 59% markup. “There’s been such a consistent pick up in momentum in anything above a billion [dollars],” Cody Powers, an M&A expert with ZS Principal, said in an interview. “I think we’re back on the gravy train of where we were a couple of years ago in terms of premiums.” In 2019, the industry ...
After a groundbreaking approval for Tecentriq, Roche has another positive early-stage lung cancer trial to celebrate. This time, the honor belongs to a targeted therapy in Alecensa. Alecensa, compared with chemotherapy, reduced the risk of tumor recurrence or death when used after surgery in certain non-small cell lung cancer patients, Roche said Friday. The patients had ALK-positive, stage 1b to 3a tumors that were completely resected before taking Alecensa. The positive readout, from the ALINA trial, makes Alecensa the first ALK inhibitor to show a benefit in early-stage NSCLC in a phase 3 trial, Roche noted. Data on patient survival remain immature. But the Swiss pharma said it’ll submit the results to the FDA and the European Medicines Agency for a potential label expansion. “If approved, Alecensa has the potential to treat cancer before it has spread in a setting where treatment can increase the chances of cure,” Roche’s chief ...
With Xspray Pharma and Eversana’s cancer med hitting a regulatory setback, a launch in the second half of 2023 now looks unlikely. That’s good news for Bristol Myers Squibb, which has secured a few more competition-free months for its aging leukemia blockbuster Sprycel. Swedish drugmaker Xspray has received an FDA complete response letter on its application for its first product Dasynoc. In issuing the rejection, the FDA requested additional information on the drug’s dosing plus greater clarity around a third-party manufacturing facility. Xspray is seeking an FDA nod for Dasynoc to treat chronic myeloid leukemia (CML) and acute lymphatic leukemia (ALL). Despite issuing the rejection, Xspray said the FDA signed off on “critical aspects” of the application and did not identify any deficiencies pertaining to the drug’s stability or clinical data, the company said in a release Tuesday. Xspray is positioning its drug as a rival to BMS’ Sprycel, which clinched its first approval in CML back ...
Earlier this year, when Astellas announced that Naoki Okamura was taking over as CEO, the Japanese company said that 2023 was the right time for it to “go on the aggressive to further stimulate growth.”It took Okamura less than a month into his tenure—which began April 1—to act on the company’s game plan. On April 29, he struck the largest acquisition in Astellas’ history, a $5.9 billion buyout of Iveric Bio. With the New Jersey-based biotech two months away from an FDA decision on its geographic atrophy (GA) eye disease candidate Zimura, Astellas hopes to become a major player in a new arena. “We had been closely watching the lead program for Iveric for a very long time, probably seven, eight years,” Okamura said in an interview with Fierce Pharma. “Because the modality of that project is very new to us, we were kind of hesitant to do any partnerships ...
Legend Biotech and Johnson & Johnson are moving fast in their efforts to forward their CAR-T standout Carvykti.Two days after presenting remarkable data from a phase 3 trial in multiple myeloma at the American Society of Clinical Oncology annual meeting, the companies have filed with the FDA for expanded use of the cell therapy. After gaining approval 16 months ago for Carvykti to treat multiple myeloma patients following four or more lines of therapy, the companies hope to get the U.S. regulator to sign off on its use at an earlier stage of treatment. Specifically, Legend and J&J submitted an application seeking an approval to treat patients with relapsed and lenalidomide-refractory multiple myeloma who have received at least one prior line of therapy, including a protease inhibitor, such as Takeda’s Velclade, and an immunomodulatory agent, such as Bristol Myers Squibb’s Revlimid. With such an approval, Carvytki could leapfrog BMS’ multiple ...
A new report by Edelman reveals an East-West divide in how people around the world view pharmaceutical businesses’ trustworthiness and their commitment “to do what is right.” Now in its second year, Edelman’s report found that people living in China, which is the world’s second largest and fastest growing pharma market, reported the highest level of trust in the industry (89%). China was closely followed by India, the world’s largest producer of generic medicines, where 86% of people trust the pharma industry. However, the numbers drop significantly in the West. In the U.K., 60% of people trust the pharma industry to do what is right, and the number dips to 55% in Germany and 52% in France. In the U.S., the world’s largest pharma market, 54% of people trust the pharma industry. The lowest ranking comes from Japan, home of Big Pharmas Eisai and Takeda, which registered a score of ...
By Jef Akst Pictured: Illustration of a human body with the intestines highlighted/iStock, Rasi Bhadramani At $17 per share, Ironwood Pharmaceuticals has agreed to buy VectivBio for around $1 billion in a cash deal. In doing so, the Boston-based company, which already markets Linzess for irritable bowel syndrome and constipation with AbbVie, will expand its gastrointestinal drug portfolio. The Swiss biotech’s most advanced product is apraglutide, being developed for short bowel syndrome with intestinal failure (SBS-IF) that affects some 18,000 adult patients in the U.S., Europe and Japan, according to the Ironwood press release. People with the disorder are unable to absorb adequate nutrition from their food, leading to impaired quality of life and sometimes death. Takeda Pharmaceuticals has an approved drug, Gattex, that aims to treat short bowel syndrome but requires daily injections. Apraglutide is being tested in a Phase III study involving weekly injections. “There’s certainly challenges with ...
Beth Snyder Bulik Senior Editor AbbVie picked up another indication for blockbuster Rinvoq on Thursday, this time for Crohn’s disease. The seventh FDA approval for the JAK inhibitor is specifically for use in moderate to severe Crohn’s patients who have had inadequate response or intolerance of at least one TNF blocker. While there are several other biologics already on the market to treat moderately to severely active Crohn’s including J&J’s Stelara, Takeda’s Entyvio and AbbVie’s own Skyrizi, the FDA noted that Rinvoq is the first oral drug. The approval was based on results from three studies, the U-EXCEED and U-EXCEL initial trial and the U-ENDURE maintenance trial, determining statistical significance in the co-primary endpoints of endoscopic response and clinical remission. AbbVie consultant and gastroenterologist Edward Loftus, who was a U-EXCEL investigator, said in a news release, “Based on the clinical trial results, treatment with RINVOQ shows both early and long-term ...
Just like how the Avengers have repeatedly kept the world safe from Ultron, people need to protect themselves by updating their COVID-19 vaccination with the latest booster. That’s the message Pfizer and BioNTech are trying to get across in a new custom comic book partnered with Marvel. The companies unveiled the project Tuesday. “We are proud to work with Marvel, which is so firmly entrenched in global culture and entertainment, to help remind people of the actions they can each take to help protect themselves, similarly to how the Avengers protect their community,” Pfizer said in a statement shared with Fierce Pharma Marketing. The new comic, titled “Everyday Heroes,” represents Pfizer flexing its marketing muscle. COVID vaccines are slated to switch to the private commercial market after the U.S. government failed to secure additional funding from Congress. As Pfizer CEO Albert Bourla, Ph.D., has said, Pfizer can be “even more competitive” and ...
Reviewed by Emily Henderson, B.Sc.Apr 17 2023 A regimen of pre-surgical immunotherapy and chemotherapy followed by post-surgical immunotherapy significantly improved event-free survival (EFS) and pathologic complete response (pCR) rates compared to chemotherapy alone for patients with operable non-small cell lung cancer (NSCLC), according to Phase III trial results presented today by researchers from The University of Texas MD Anderson Cancer Center at the American Association for Cancer Research (AACR) Annual Meeting 2023. The AEGEAN trial evaluated durvalumab given perioperatively, meaning therapy is given both before and after surgery. Participants on the trial received either pre-surgical (neoadjuvant) durvalumab and platinum-based chemotherapy followed by post-surgical (adjuvant) durvalumab or neoadjuvant placebo and chemotherapy followed by adjuvant placebo. These represent the first data presented on the benefits of perioperative immunotherapy for resectable NSCLC and adds to the growing evidence supporting the benefits of both neoadjuvant and adjuvant immunotherapy for these patients. Our goal is to increase cures for lung cancer. ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.