Search Results for “AstraZeneca” – Page 20 – media

With trial win, Seagen’s breast cancer drug Tukysa boosts Roche’s Kadcyla—and Pfizer’s $43B buyout

Pfizer is shelling out $43 billion to acquire Seagen primarily for the Seattle biotech’s antibody-drug conjugate (ADC) capabilities. But a trial win for a small-molecule cancer drug makes the deal more attractive. Seagen on Wednesday said a phase 3 trial testing a combination of its Tukysa and Roche’s Kadcyla has hit its main goal in patients with previously treated HER2-positive breast cancer. Compared with Kadcyla and placebo, the combo significantly reduced the risk of tumor progression or death, Seagen said. Data on patient survival remain immature. Seagen plans to share the detailed results from the HER2CLIMB-02 trial at a medical meeting and will discuss them with the FDA, the company’s R&D chief, Roger Dansey, said in a statement. The positive results further de-risk the Seagen acquisition by Pfizer, Leerink Partners analysts said in a Wednesday note. Since securing FDA approval in 2020, Tukysa has been used alongside trastuzumab (Herceptin) and ...
- Source: drugdu
- 152
- August 19, 2023
FDA Approves J&J’s Akeega for BRCA-Positive Prostate Cancer

By Tristan Manalac Pictured: Janssen headquarters in California/iStock, Sundry Photography The FDA on Friday signed off on Janssen Pharmaceutical’s niraparib and abiraterone acetate tablets, now to be marketed as Akeega, for the treatment of metastatic castration-resistant prostate cancer in patients carrying the BRCA mutation. According to Janssen’s announcement, Akeega is the first dual-action tablet that combines the activity of a PARP inhibitor with abiraterone acetate, an androgen biosynthesis inhibitor sold by the company under the brand name Zytiga. Janssen is a subsidiary of Johnson & Johnson. The approval covers a combination regimen of Akeega with prednisone and is based on data from the Phase III MAGNITUDE study, a randomized, double-blinded and placebo-controlled trial with 765 participants. Compared with Zytiga plus prednisone, the Akeega-based regimen significantly improved radiographic progression-free survival by 47% in BRCA-positive patients. Akeega also led to a trend toward better overall survival, though this effect fell short of ...
- Source: drugdu
- 187
- August 16, 2023
GSK beats Merck to first PD-1 approval in newly diagnosed endometrial cancer

GSK has won the first FDA approval for an immunotherapy to treat certain patients with newly diagnosed endometrial cancer. But the industry-first go-ahead is tempered with a label limitation. The FDA has cleared Jemperli as an add-on to chemotherapy for patients with primary advanced or recurrent endometrial cancer, GSK said Monday. To be eligible for the therapy, the patient’s tumor must be mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H), both terms that describe a type of genetic abormality. The approval comes nearly two months ahead of schedule and puts Jemperli ahead of Merck & Co.’s rival PD-1 inhibitor Keytruda, which is also gunning for the first-line endometrial cancer use. But the dMMR/MSI-H restriction comes as a bit of a disappointment for the GSK drug. By GSK’s estimate, about 15% to 20% of the roughly 60,000 new cases of endometrial cancer each year in the U.S. will be diagnosed at an advanced ...
- Source: drugdu
- 109
- August 2, 2023
UK Probes Weight Loss, Diabetes Drugs for Suicidal Ideation and Self-Harm Risk

The UK’s Medicines and Healthcare products Regulatory Agency said Wednesday that it is reviewing a class of drugs used for obesity and diabetes treatment after reports of self-injury and suicidal thoughts in patients. The probe by the MHRA comes shortly after the European Medicines Agency (EMA) expanded its own investigation into the GLP-1 receptor agonist class of drugs. This includes medications like Saxenda (liraglutide), Wegovy (semaglutide) and Ozempic (semaglutide) produced by Danish pharma company Novo Nordisk. According to reporting by Reuters, the MHRA also confirmed AstraZeneca’s Bydureon (exenatide), Sanofi’s lixisenatide, and Eli Lilly’s dulaglutide were also being included in the review. Novo Nordisk told Reuters that it had received a request from the MHRA about the investigation. “The review is ongoing and a response will be provided within the requested timelines,” Novo Nordisk said in a statement. The MHRA review kicked off July 12, though the agency could not specify when it would ...
- Source: drugdu
- 119
- July 28, 2023
FibroGen CEO Conterno, Who Scrapped Post-Lilly Plans Over Roxadustat Hype, Resigns After Launch Setbacks

Hopes around FibroGen’s anemia drug roxadustat were high in early 2020 when Enrique Conterno arrived as the company’s new CEO. He’d just come off a 27-year-run at Eli Lilly and was, according to an analyst interview at the time, “most impressed” by the commercial opportunity for roxadustat.But the last few years have not been kind to FibroGen and AstraZeneca’s drug, with an FDA rejection, commercial disappointments and a clinical trial flop considerably blunting the oral anemia med’s trajectory. It’s against that backdrop—plus a major layoff round—that Conterno, who’s been chief at FibroGen since January 2020, is now hitting the exit. Conterno has resigned from the FibroGen CEO post for “personal reasons,” the company said Tuesday. As FibroGen looks for a permanent successor, the company’s chief commercial officer Thane Wettig will don the mantle of interim chief executive officer. To support Wettig, Conterno plans to stick around as a special advisor to ...
- Source: drugdu
- 252
- July 27, 2023
Bavarian Nordic Falls by RSV Vaccine Wayside After Phase III Failure

The respiratory syncytial virus (RSV) vaccine arena lost a competitor on Saturday 21 July after Danish company Bavarian Nordic shelved its programme following missed endpoints in a Phase III trial. The candidate, named MVA-BN RSV, failed to meet the co-primary endpoint of severe lower respiratory tract disease (LRTD) based on at least three pre-defined symptoms, only demonstrating a 42.9% efficacy. The vaccine did, however, have a 59% efficacy in preventing at least two pre-defined LRTD symptoms. The randomised, double-blind Phase III trial (NCT05238025) involved 20,000 older adults across centres in the US and Germany. As a result of the programme termination, Bavarian Nordic has also ended its partnership with Nuance Pharma, a Chinese pharma company brought in to develop and launch the vaccine for Asian markets. Although Bavarian Nordic’s president and CEO Paul Chaplin said in a statement that the blow would impact short-term growth, ...
- Source: drugdu
- 112
- July 26, 2023
Roche Expands Into RNAi Through Alnylam Alliance on Hypertension Drug

Photo: Giuseppe Aresu/Bloomberg, via Getty Images Alnylam pioneered RNA interference drugs for rare disease. The biotech aims to bring RNAI to prevalent disorders and its alliance with Roche on the drug zilebesiran for hypertension better positions the company to achieve this goal. Cardiometabolic disease isn’t a big part of Roche’s drug portfolio or pipeline, but the pharmaceutical giant is trying to change that with a deal to share in the development of an experimental Alnylam Pharmaceuticals hypertension drug that could offer patients efficacy and dosing advantages. According to deal terms announced Monday, Roche is paying $310 million for outside-of-the-U.S. rights to the drug, zilebesiran. The companies will share in the development of the RNA therapy for hypertension. Roche has the opportunity to lead future development of the drug for other indications. Cambridge, Massachusetts-based Alnylam is a pioneer among companies developing therapies that leverage RNA interference, a pathway in ...
- Source: drugdu
- 113
- July 26, 2023
Sanofi Expects Infant RSV Shot to Roll Out Before Respiratory Virus Season This Fall

Sanofi expects its infant RSV shot to roll out in the U.S. before respiratory virus season this fall, a company spokesperson said Friday. The Food and Drug Administration on Monday approved Beyfortus, a monoclonal antibody that is administered as a single dose to infants before or during their first respiratory syncytial virus season. The Sanofi spokesperson said the company does not expect any challenges with manufacturing or capacity to meet demand this RSV season. The French drugmaker jointly developed Beyfortus with AstraZeneca , which is based in England. A panel of independent advisors to the Centers for Disease Control and Prevention will meet on Aug. 3 to make recommendations about how the shot should be administered. Sanofi is working with the panel to place Beyfortus on the U.S. childhood immunization schedule, the company spokesperson said. The Affordable Care Act requires most private insurance to cover ...
- Source: drugdu
- 127
- July 25, 2023
Pieris Pharma Lays off 70% of Workforce Amid Company Restructuring

Pieris Pharmaceuticals will be laying off 70% of its workforce as part of a corporate restructuring following the termination of its collaboration with British pharmaceutical company AstraZeneca. After encountering challenges such as the termination of patient recruitment in a Phase IIa asthma trial of the drug elarekibep, AstraZeneca decided to end its R&D partnership with Pieris, per the 18 July announcement. The company has returned elakeribep and terminated the existing discovery program. The two companies announced their collaboration to develop inhaled engineered proteins in May 2017. As part of the agreement, AstraZeneca has agreed to fund all clinical development and commercialisation programmes of the lead candidate, elarekibep. Also known as PRS-060, elarekibep is a type of engineered protein that targets interleukin-4 receptor alpha, which is based on Pieris’ Anticalin platform. The companies also agreed to develop four additional treatments based on the platform for different targets ...
- Source: drugdu
- 91
- July 21, 2023
Samsung Biologics, After Expanding Pfizer Collab, Inks Novartis Production Deal Worth $391M

Just days after sewing up a pair of $897 million deals with Pfizer, Samsung Biologics has added a few hundred million dollars more to its partnership cash pile—this time courtesy of an expanded pact with Novartis. Monday, Samsung Bio said in a regulatory filing that it’s inked a $390.9 million deal to help crank out Novartis drugs. The latest production pact builds on an earlier Samsung-Novartis tie-up worth $81 million in June 2022. Last week, meanwhile, Samsung Bio said Pfizer had added $486 million to two biosimilar production accords the companies made in early 2023. In June, the partners signed a contract for the Korean CDMO to produce biosimilar drugs in the fields of immunology, oncology and inflammation. And in March, the companies linked up on a deal worth $193 million, according to a regulatory filing. Samsung’s Novartis deal comes in below that Pfizer deal from June. Still, the Novartis tie-up now represents ...
- Source: drugdu
- 137
- July 12, 2023

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