Catalent wraps up San Diego site buildout as it continues to make waves with global acquisitions

Catalent CEO John Chiminski (Jeff Rumans)

November 4, 2021 11:20 AM EDT

Catalent wraps up San Diego site buildout as it continues to make waves with global acquisitions

Josh Sullivan

Just weeks after Catalent opened a newly acquired site in Shiga, Japan, the CDMO giant announced the opening of a new facility in San Diego to up its clinical packaging and distribution solutions on the West Coast.

The facility is 24,000 square feet and located within a mile of the company’s early-phase oral drug product center of excellence. It supports clinical studies for Phases I through III, and end-to-end services.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

The Factors Driving a Rapid Evolution of Gene & Cell Therapy and CAR-T Clinical Research in APAC

Kasey Kime

Director of Regulatory Affairs at Novotech

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region.

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

September 24, 2022 06:00 AM EDT

Weekly

The Endpoints 11; bluebird's $3M gene therapy; Biogen tout new neuro data; Harsh reviews for cancer drugs; and more

Amber Tong

Senior Editor

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

September 23, 2022 12:30 PM EDT

Pharma

Manufacturing

EMA warns of shortages of two Boehringer heart drugs due to a spike in demand

Tyler Patchen

News Reporter

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

ENDPOINTS CAREERS

Head of Site Finance mRNA - Cell & Gene

Lonza

Geleen, Netherland

view job offer post your job now

September 22, 2022 07:01 AM EDTUpdated September 23, 04:21 AM

Special

The Endpoints 11: The top private biotechs in pursuit of new drugs. Pushing the envelope with powerful new technologies

John Carroll

Editor & Founder

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

Premium subscription required

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

September 23, 2022 02:29 PM EDTUpdated 04:16 PM

Manufacturing

Fujifilm continues CDMO expansion, breaking ground on $435M UK site

Tyler Patchen

News Reporter

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.

Rahul Singhvi, Resilience CEO

September 21, 2022 02:55 PM EDTUpdated 05:05 PM

Pharma

Manufacturing

Q&A: Resilience boss Rahul Singhvi talks $2B US biomanufacturing initiative and post Series D deals

Tyler Patchen

News Reporter

When the Biden administration announced last week, through an executive order, that it is investing $2 billion into domestic efforts to increase biotechnology and biomanufacturing efforts, a lot of ears perked up in the wider manufacturing world. Funding is going towards manufacturing infrastructure, training, R&D and security measures, among others, something that domestic manufacturers are bullish about.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

September 23, 2022 02:38 PM EDTUpdated 03:37 PM

R&D

AstraZeneca, Merck cull one Lynparza indication in heavily pretreated ovarian cancer patients

Paul Schloesser

Associate Editor

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

ENDPOINTS CAREERS

Head of Quality Systems

Lonza

Lexington, MA, USA

view job offer post your job now

September 23, 2022 01:48 PM EDT

Pharma

FDA+

Manufacturing

Another Cipla site lands a Form 483 over cleaning issues and QC controls

Tyler Patchen

News Reporter

A Cipla drug manufacturing site in India has once again landed in the crosshairs of FDA inspectors.

The facility in question is Cipla’s drug manufacturing facility in the village of Verna, in the state of Goa in India’s southwest. In a sign that foreign inspections might ramp up again, the FDA’s visit from Aug. 16 to Aug. 22 uncovered six observations.

The 11-page report noted that environmental monitoring at the site did not properly ensure that microbial contaminants were not making any impact in the aseptic filling areas. It also found that procedures meant to stop microbial contamination were not adequately conducted in aseptic areas of the facility.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

Solicitor General Elizabeth Prelogar

September 23, 2022 01:17 PM EDT

Pharma

Law

Should SCOTUS hear Amgen's Repatha case? Solicitor general says no

Nicole DeFeudis

Editor

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.