October 25, 2019 10:34 AM EDTUpdated 03:03 PM

Christopher Haqq joins Elicio to hunt father's RAS cancer; Kronos expands top team with Gilead, Baylor vets

ENDPOINTS

Christopher Haqq’s father taught him how to build volcanoes in their backyard. He was a beloved chemistry teacher for 30 years who inspired many students, Haqq says, and sent him down a path through volcanoes and up into oncology.

Christopher Haqq

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.

2023 Spotlight on the Future of Drug Development for Small and Mid-Sized Biotechs

Allucent

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry. This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward. It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

December 1, 2022 03:46 PM ESTUpdated 04:58 PM

FDA+

Updated: FDA remains silent on orphan drug exclusivity after last year's court loss

Zachary Brennan

Senior Editor

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

December 5, 2022 03:04 PM EST

Pharma

Manufacturing

Pfizer makes another billion-dollar investment in Europe and expands again in Michigan

Tyler Patchen

News Reporter

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.

ENDPOINTS CAREERS

Chief People Officer

Adimab, LLC

Lebanon, NH, USA

view job offer post your job now

Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

December 5, 2022 01:46 PM ESTUpdated 02:21 PM

Pharma

FDA+

Novartis bolsters Pluvicto's case in prostate cancer with PhIII results

Nicole DeFeudis

Editor

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.

Rick Modi, Affinia Therapeutics CEO

December 5, 2022 08:26 AM ESTUpdated 08:58 AM

Financing

Startups

Cell/Gene Tx

Vertex-partnered gene therapy biotech Affinia scraps IPO plans

Kyle LaHucik

Associate Editor

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.

December 5, 2022 07:35 AM ESTUpdated 07:47 AM

Deals

After M&A fell through, TherapeuticsMD sells hormone therapy, contraceptive ring for $140M cash plus royalties