| 07.11.22 | MacroGenics shutters cancer trial after 7 di e; 'Biotech sisterhood’ see R oe ruling as a call to action

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Aligning CMC with Clinical Trials in 505(b)(2) Product Development

In 505(b)(2) development, a sponsor can often abbreviate its nonclinical and clinical program by using already-available regulatory information, and the CMC program becomes a rate-limiting factor at the time of regulatory filings as a result. Download our guide to learn what phase-appropriate CMC issues you should consider when developing a 505(b)(2) product.

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Today's Rundown

MacroGenics closes solid tumor clinical trial after 7 people die 'Organize. Align': Women in biotech see Roe v. Wade ruling as a call to action Vertex absorbs ViaCyte and its stem cell-based diabetes treatment for $320M, clearing out competition Sponsored: Ramp up your AAV production with Lonza’s HEK 293 cell line and patented vectors technologies Sanofi preps hemophilia duo for patients seeking as 'normal a life as possible' Sponsored: Decentralized clinical trials, patient experience and the role of supply chain management Emerald Health sees CEO, CFO resign as CBD-focused company faces fraud allegations Pliant surges as phase 2 data raise hopes for lung disease asset Quelling star-shaped brain cells may prevent long-term brain injury deficits Innoviva snaps up La Jolla and its 2 FDA-approved drugs for $149M Exelixis trots out combo win for Cabometyx and BMS meds in kidney cancer. Will the FDA get on board? Dr. Reddy's reveals FDA write-up at Indian formulation plant Primary care company Forward cuts 5% of workforce amid 'extremely tough' market conditions FDA denies Lumos Diagnostics' bid for rapid test to differentiate between bacterial, viral infections

Featured Story

MacroGenics closes solid tumor clinical trial after 7 people die

By Nick Paul Taylor

MacroGenics has closed a phase 2 clinical trial of its anti-cancer antibody enoblituzumab after learning of seven deaths potentially associated with hemorrhagic events. The setback means two of MacroGenics’ three attacks on B7-H3 have hit setbacks but the biotech is forging ahead with the third candidate.


This week's sponsor is Aldevron.

'Organize. Align': Women in biotech see Roe v. Wade ruling as a call to action

By Annalee Armstrong

More than 100 women in biotech have signed on to a letter decrying the Supreme Court's ruling overturning Roe v. Wade. They say this is only the beginning of their activism.

Vertex absorbs ViaCyte and its stem cell-based diabetes treatment for $320M, clearing out competition

By Max Bayer

Just a week after Vertex’s stem cell therapy to treat type 1 diabetes was released from an FDA clinical hold, the company is clearing out potential competition by buying ViaCyte for $320 million.

Sanofi presented data on its broad bleeding disorder pipeline at the International Society on Thrombosis and Haemostasis 2022 Congress Sunday, showcasing key late-stage data on two therapies: efanesoctocog alfa and fitusiran.

Emerald Health Pharmaceuticals’ CEO and CFO have both stood down as the CBD-focused company battles fraud allegations from the SEC.

Pliant surges as phase 2 data raise hopes for lung disease asset

By Nick Paul Taylor

Pliant Therapeutics’ idiopathic pulmonary fibrosis (IPF) candidate has impressed investors. With phase 2 data supporting more development, the biotech boasted a 60%-plus stock surge on Monday morning.

Quelling star-shaped brain cells may prevent long-term brain injury deficits

By Gabrielle Masson

Researchers have discovered that quelling astrocytes—star-shaped brain cells—might fight long-term effects of traumatic brain injury, pointing to a protein involved in the process that could serve as a potential therapeutic target.

Innoviva snaps up La Jolla and its 2 FDA-approved drugs for $149M

By Kevin Dunleavy

With sales of blood pressure medicine Giapreza lagging, La Jolla has sold out to royalty management company Innoviva for $149 million. The Waltham, Massachusetts, company intends to pay $5.95 per share, which is a 70% premium on La Jolla’s 30-day share price.

Exelixis trots out combo win for Cabometyx and BMS meds in kidney cancer. Will the FDA get on board?

By Angus Liu

Bristol Myers Squibb's Opdivo and Yervoy and Exelixis' Cabometyx have their own newly diagnosed kidney cancer nods. Now, Exelixis showed that adding its drug to the immuno-oncology duo can confer additional benefits, but so far only on stalling tumor progression.

Dr. Reddy's reveals FDA write-up at Indian formulation plant

By Fraiser Kansteiner

Following a preapproval inspection at one of the drugmaker's formulations manufacturing sites, Dr. Reddy’s says the FDA slapped the company with a two-observation Form 483.

Primary care company Forward cuts 5% of workforce amid 'extremely tough' market conditions

By Heather Landi

Primary care company Forward, reportedly worth more than $1 billion, is the latest digital health company to feel pressure from the current market downturn.

FDA denies Lumos Diagnostics' bid for rapid test to differentiate between bacterial, viral infections

By Andrea Park

Lumos Diagnostics’ FebriDx point-of-care test will have to wait a bit longer to see the light of day in the U.S., as the Australian company announced Monday that its 510(k) submission to the FDA has been rejected.