J&J’s Janssen ‘Blue Jacket’ fashion show returns to runway for … – Endpoints News

February 2, 2023 01:42 PM EST

The annual “Blue Jacket” Fashion Week runway show is more than just showing off high-style looks for sponsor Johnson & Johnson’s Janssen. It’s about turning up the runway lights on prostate cancer, and especially the need for diagnosis and treatment for Black men.

Celebrity models for the event on Wednesday in New York included a diverse group of fashionistas, including chef Marcus Samuelsson, CNN TV host Don Lemon, scientist and TV show host Bill Nye and actors London Brown, Mario Cantone, Dominic Fumusa and Eric West.

February 2, 2023 01:05 PM EST

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

February 2, 2023 01:37 PM EST

The use of real-world evidence to inform the FDA’s decision-making continues apace, with the agency releasing new draft guidance yesterday on how sponsors can compare outcomes of trial participants receiving a test treatment with outcomes in a group of people external to the trial.

The practice of externally controlled trials is common, particularly in oncology or other difficult areas where it’s not ethical or feasible to use internal controls.

February 1, 2023 03:11 PM EST

With Novo Nordisk’s obesity treatment Wegovy fully back in stock in December, sales are beginning to soar, the Danish pharma reported during its annual earnings call on Wednesday. Total scripts of the glucagon-like peptide 1 (GLP-1) Wegovy topped 37,000 weekly in mid-January, a hockey stick uptick from end-of-year levels below 15,000 per week.

The new prescriptions come on top of the overall momentum of Novo obesity drug sales in 2022, although the then supply-constrained Wegovy was only part of that. Sibling obesity med Saxenda accounted for DKK 10.7 billion ($1.58 billion) of the total DKK 16.9 billion ($2.49 billion), or about 63%, in Novo Nordisk’s reported obesity segment sales.

February 2, 2023 06:49 AM EST

GSK has secured the first of four US approvals it’s hoping for this year, as the FDA greenlit daprodustat as a treatment for anemia due to chronic kidney disease.

But the FDA limited the use of the drug, to be marketed as Jesduvroq, to patients who have been receiving dialysis for at least four months and stopped short of approving it for patients not dependent on dialysis — in line with the recommendations of the advisory committee it consulted.

February 2, 2023 11:51 AM EST

As fourth quarter earnings come in, Big Pharmas are disclosing changes to their pipelines during their investor calls, and sometimes more quietly in presentation appendices.

Merck dropped its chikungunya vaccine candidate, which completed a Phase II study. Merck acquired the vaccine through its purchase of Themis Bioscience in 2020. In developing a vaccine for chikungunya, a mosquito-borne virus, Valneva is the frontrunner, as it submitted its vaccine to the FDA at the end of December.

February 2, 2023 11:34 AM EST

Karuna Therapeutics is looking to compete with Boehringer Ingelheim on depression and anxiety with a new license to Goldfinch Bio’s assets, starting with $15 million to the shuttered biotech.

Karuna steps into an arena already being tested by Boehringer in multiple Phase II studies — the two are targeting transient receptor potential canonical 4 and 5, or TRPC4/5, which is thought to have a role in neuroscience indications. Goldfinch’s asset went through a Phase II in kidney diseases, but Karuna’s sights are set on mood and anxiety disorders for now.

February 2, 2023 12:29 PM EST

Catalent is opening the doors to a new plasmid DNA manufacturing site at one of its core sites in Europe.

The new 12,000-square-foot plasmid manufacturing site is located in its cell therapy center in Gosselies, Belgium, and has multiple cleanrooms meant to produce cGMP-grade plasmid DNA for clinical and commercial purposes. The site will also see Catalent producing plasmids that are intended to be used by cell and gene companies.

January 31, 2023 02:43 PM EST

National Football League games, and big viewing audiences, are typically popular with drugmakers looking to advertise product brands. However, this year, Pfizer’s broader Covid vaccine encouragement and treatment awareness advertising led the pharma charge by a wide margin during both NFL regular season and postseason national broadcasts, according to real-time TV ad tracker iSpot.tv.

Pfizer spent almost $90 million during the regular season and another $18 million during the playoffs ahead of all pharma companies and brands, iSpot reported in a tabulation for Endpoints News.

February 2, 2023 07:43 AM ESTUpdated 10:09 AM

Roche announced another leadership shuffle Thursday morning – the head of global product strategy, Teresa Graham, will take over as CEO of Roche Pharmaceuticals in March while the company’s corporate executive committee will make a spot for Levi Garraway, CMO and executive VP of global product development.

Thomas Schinecker will take over the top spot as Roche group CEO in March, leaving his spot as head of diagnostics.