Pfizer CEO Albert Bourla (Evan Vucci, AP Images)

Pfiz­er opens doors at newest gene ther­a­py site in NC as part of $800M push in­to next-gen drugs

The Covid-19 pandemic has been an extremely profitable time for Pfizer, and the massive drugmaker is using that leverage to advance its portfolio writ large. Now, Pfizer’s emerging gene therapy biz will have some new elbow room as it continues to grow in the coming years.

Pfizer this week opened a $68.5 million gene therapy manufacturing facility in Durham, North Carolina, as part of a multi-year, $800 million plan to outfit its next-gen therapeutics business, the company said Wednesday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,400+ biopharma pros reading Endpoints daily — and it's free.

George Scangos (L) and Marianne De Backer

Pi­o­neer­ing biotech icon George Scan­gos hands in his re­tire­ment pa­pers — and this time it’s for re­al

George Scangos, one of the all-time great biotech CEOs, says the time has come to turn over the reins one last time.

The 74-year-old biotech legend spent close to three decades in a CEO post. The first was at Exelixis — which is still heavily focused on a drug Scangos advanced in the clinic. The second “retirement” was at Biogen, where he and his team were credited with a big turnaround with the now fading MS blockbuster Tecfidera. And the third comes at Vir, where he traded in his Big Biotech credentials for a marquee founder’s role back on the West Coast, hammering out a Covid-19 alliance with Hal Barron — then R&D chief at GSK — and breaking new ground on infectious diseases with some high-powered venture players.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Jeanne Loring, director of the Center for Regenerative Medicine (Credit: Jamie Scott Lytle)

A stem cell pi­o­neer sent an ex­per­i­ment in­to space. Pa­tients are the next fron­tier

Last July, Jeanne Loring stood on a dirt road surrounded by Florida swampland and watched as a nearby SpaceX rocket blasted into the sky. The payload included a very personal belonging: cell clusters mimicking parts of her brain.

For more than two decades, Loring has been at the forefront of a stem cell field that always seems on the brink of becoming the next thing in medicine, but has been slow to lift off.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

FDA takes next step in Tor­rent Phar­ma­ceu­ti­cal­s' trou­bled In­dia plant saga, is­sues OAI

The FDA has handed Torrent Pharmaceuticals an official action indicated (OAI) status for a previously inspected manufacturing facility in India.

Torrent Pharma sent a letter to the National Stock Exchange of India earlier this week with word that the manufacturer has received a “communication from the FDA determining the inspection classification as ‘Official Action Indicated’ (OAI)” for one of its sites. An OAI classification from the FDA comes after the agency has completed an inspection and determines if the facility complies with the applicable laws and regulations. Being given an OAI classification means that regulatory or administrative actions will be recommended to Torrent. However, the details on the recommended actions have not been given.

Man­u­fac­tur­ing roundup: AGC Bi­o­log­ics to man­u­fac­ture di­a­betes ther­a­py; Cam­brex caps ac­qui­si­tion of Snap­drag­on Chem­istry

The Washington-based CDMO AGC Biologics has been tapped to manufacture the type 1 diabetes treatment Tzield from Provention Bio.

AGC Biologics will produce Tzield at its Seattle protein biologics site. It was chosen after AGC helped to guide the product through process performance qualification (PPQ) manufacturing and validation batches, and, ultimately, FDA approval. Tzield is the only immunomodulatory treatment approved to delay the onset of Stage 3, type 1 diabetes in children and adults aged eight and older.

In­vestor 'misalign­men­t' leads to tR­NA biotech's shut­ter­ing

A small biotech looking to carve a lane in the tRNA field has folded, an investor and a co-founder confirmed to Endpoints News.

Similar to Flagship’s Alltrna and other upstarts like Takeda-backed hC Bioscience, the now-shuttered Theonys was attempting to go after transfer RNA, seen as a potential Swiss Army knife in the broader RNA therapeutics space. The idea is that one tRNA drug could be used across a galaxy of disorders and diseases.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,400+ biopharma pros reading Endpoints daily — and it's free.

Al Gianchetti, XyloCor CEO

Xy­lo­Cor wraps up PhII for heart dis­ease gene ther­a­py, plans for piv­otal tri­al

XyloCor Therapeutics says patients with heart disease who got its gene therapy could exercise for longer and had fewer chest pain attacks. The biotech announced it completed a Phase I/II trial of the gene therapy Thursday morning, and plans to move forward with a pivotal trial.

In the Phase II portion of the trial, 28 patients with angina (or chest pain) caused by coronary artery disease and who had no other treatment options were enrolled and were given the highest tested dose from the first part of the trial. Patients were followed for six months.

Matthew Stober, newly-appointed Abzena CEO (Abzena)

Abzena lays off more than 60 em­ploy­ees in Cal­i­for­nia

Contract manufacturer Abzena has permanently laid off 66 employees at one of its San Diego sites, marking the latest in a string of layoffs spanning the biotech industry.

The layoffs took effect on Jan. 11 at the company’s 8810 Rehco Road site, according to a WARN notice filed with the Employment Development Department of California.

Abzena does have another location in the San Diego area, where the manufacturer invested $60 million and added 50,000 square feet in 2020. Endpoints News reached out to Abzena but has not received a response as of press time.