Sanofi R&D director John Reed and Innovent CEO Michael Yu

August 4, 2022 01:50 PM EDT

Sanofi fronts €300M to partner up with Innovent on China market, eyeing quick pivot to commercialization

John Carroll

Editor & Founder

Sanofi has found a high-profile partner in China to take two of its top cancer drug prospects through the clinic and onto the big Asian market. And they’re buying into the partner’s stock — at a significant premium — to make that happen.

At the end of the day in Europe, Paris-based Sanofi spotlighted a deal with Innovent to acquire €300 million in the Chinese pharma’s shares, at a 20% markup, with an option on €300 million more at a later date.

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

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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.

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.

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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.

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Tim Walbert, Horizon Therapeutics CEO (via YouTube)

December 5, 2022 01:44 PM EST

Deals

Pharma

And then there were two: Janssen bows out of Horizon takeover negotiations

Paul Schloesser

Associate Editor

Horizon Therapeutics announced last week that it was in talks with three pharmaceutical giants that could take over the company. You can now remove one of them from the equation.

J&J’s Janssen, after Horizon reported its initial involvement in early discussions to acquire the rare disease biotech, issued a statement Saturday that said Janssen “does not intend to make an offer for Horizon,” and that Janssen is bound by restrictions set in Rule 2.8 of the Irish Takeover Rules. These rules are in place for any company interested in taking over Irish companies, with Horizon Therapeutics currently based in Dublin.

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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.

Yuling Li, Innoforce CEO

December 5, 2022 03:38 PM EST

Pharma

Manufacturing