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As CEO bounces back from Covid-19, Apel­lis says FDA meet­ing clears path to file for an OK on Soliris ri­val

After holding up the company more than 4 months after reporting positive head-to-head data against the blockbuster drug Soliris, Apellis $APLS says it’s cleared things up with the FDA and is ready to file for an approval with their rival PNH drug pegcetacoplan.

The Waltham, MA-based biotech — whose CEO, Cedric Francois, has recovered from a bout with Covid-19 — put out the word Thursday morning that execs had a “successful outcome of the pre-NDA meeting” with the agency and they’re ready to press ahead with their filing in the second half of this year.

EMA ex­tends vir­tu­al-on­ly meet­ing pol­i­cy through Au­gust

The EMA on Tuesday announced it is extending its decision to hold all upcoming meetings virtually through August 2020 as a safety measure amid the ongoing coronavirus disease (Covid-19) pandemic.

EMA first made the shift to virtual-only meetings because of Covid-19 in March and extended the policy in April to continue through the end of May. Since mid-March, most EMA staff have worked remotely as well.

FDA, Ae­tion part­ner on re­al-world da­ta an­a­lyt­ics for Covid-19

The FDA on Tuesday said it will partner with New York-based health technology firm Aetion, Inc. to develop real-world data analytics to answer pressing questions related to coronavirus disease (Covid-19).

“Evaluation of real-world data has the potential to provide a wealth of rapid, actionable information to better understand disease symptoms, describe and measure immunity and understand available medical product supplies to help mitigate potential shortages. These data can also inform ongoing work to evaluate potential therapies, vaccines or diagnostics for COVID-19,” said FDA Principal Deputy Commissioner Amy Abernethy.

As­traZeneca, Mer­ck push block­buster fran­chise to an­oth­er key FDA ap­proval, rel­e­gat­ing a ri­val to sec­ond-fid­dle sta­tus

Prostate cancer patients have another PARP inhibitor option in a matter of days.

Clovis’ Rubraca won its prostate cancer approval on Friday, but data from AstraZeneca and Merck rival Lynparza put a damper on commercial expectations. Now, the FDA has approved Lynparza in the prostate cancer setting, months ahead of its expected decision date.

Lynparza has been approved for patients with metastatic castration-resistant prostate cancer (mCRPC), who carry BRCA or ATM mutations, which account for roughly 20-30% of patients with mCRPC. The approval was based on the late-stage PROfound trial, which found the drug eclipsed the impact of the androgen therapies at reducing the risk of disease progression or death by a sharp 66%.

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Years af­ter Keytru­da, Roche's Tecen­triq monother­a­py wins first-line NSCLC ap­proval. So does it mat­ter?

Years after Keytruda, patients with previously untreated non-small cell lung cancer (NSCLC) finally have a new checkpoint inhibitor monotherapy option: Roche’s Tecentriq.

Merck’s star drug captured this ripe indication in 2016, winning the battle for checkpoint inhibitor supremacy years ago. On Monday, the FDA approved Roche’s Tecentriq on its own for newly diagnosed, metastatic patients without EGFR or ALK mutations whose tumors carry levels of the biomarker PD-L1 registering at 50% or greater.

FDA up­dates Covid-19 clin­i­cal tri­als guid­ance to ad­dress se­ri­ous ad­verse events

The FDA last week updated its guidance on conducting clinical trials amid the coronavirus disease pandemic to address how and when sponsors and application holders should report serious adverse events (SAE).

The latest update to the guidance comes just days after FDA added new questions and answers to the document addressing the use of alternate laboratory or imaging centers, video conferencing and postmarketing studies.

As­traZeneca nabs break­through sta­tus, as $7B ADC races to block­buster sta­tus

A rapid breast cancer approval came just before New Year’s for AstraZeneca and Daiichi Sankyo’s billion-dollar antibody drug conjugate Enhertu, but the plan was never to stop there.

Today, AstraZeneca said they received breakthrough status for Enhertu in HER2-positive non-small cell lung cancer. It’s the second such designation they’ve received in a week, after the FDA granted the same recognition to Enhertu in gastric cancer. The twin designations set the British drugmaker up to market the drug in three different indications, a key validation for the massive deal CEO Pascal Soriot signed in 2019.

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Clo­vis' Rubra­ca wins prostate can­cer ap­proval, but da­ta from ri­val Lyn­parza damp­en com­mer­cial ex­pec­ta­tions

While AstraZeneca and Merck’s market-leading Lynparza seemingly pipped Clovis Oncology’s rival Rubraca in helping prostate cancer patients, Rubraca has, as expected, made it across the finish line first.

On Friday, the FDA approved Rubraca in patients with BRCA mutation-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated previously with androgen receptor-directed therapy as well as chemotherapy. The approval marks the first ever for a PARP inhibitor in the prostate cancer setting.

Af­ter a PhI­II fail­ure, the FDA de­liv­ers Blue­print an ex­pect­ed CRL

Some CRLs come as little surprise.

This morning, the FDA rejected Blueprint Medicines’ application to have their cancer drug Ayvakit (avapritinib) approved for fourth-line gastrointestinal stromal tumors, or GIST. Already, though, in late April, the drug had failed the major test for that indication: A Phase III trial pitting Ayvakit against the already-approved Bayer GIST drug, regorafenib.

Patients on regorafenib did better than those on Ayvakit. After the trial, Blueprint said they were ending the program for 3rd and 4th line GIST patients. Analysts discounted the indication from their projections.

John Reed, Sanofi R&D chief (Jeff Rumans)

Sanofi scores a snap re­view for a rare dis­ease drug, an­oth­er win for the come­back play­ers in R&D

Just a few months after spotlighting promising results from a small study for one of its rare disease drugs, the Sanofi team behind another one of their rare disease drugs is boasting that they snagged a snap review at the FDA — the kind that usually presages a quick OK.

The drug is sutimlimab, a C1s inhibitor which they picked up in their Bioverativ acquisition. The drug is used to treat cold agglutinin disease, where the immune system runs amok attacking healthy red blood cells.