IMRT, proton on par in prostate trial

Today’s Big News

Sep 30, 2024

J&J, Legend solidify Carvykti's lead in earlier multiple myeloma with strong survival showing


Kezar halts dosing and enrollment in key lupus study following 4 patient deaths


ASTRO: Randomized prostate cancer study finds no major differences between IMRT and proton beam radiation


Moderna rebuked over second successive Spikevax marketing breach


CDMOs eye industrywide growth in 2025 as many spurn BIOSECURE Act, CPHI research shows


Roche celebrates Pharma Day by buying Regor's CDK inhibitors, regenerative med-focused AntlerA


Remedee Labs nabs European approval for fibromyalgia wristband therapy

 

Featured

J&J, Legend solidify Carvykti's lead in earlier multiple myeloma with strong survival showing

After putting on a strong performance in preventing disease progression, Johnson & Johnson and Legend Biotech’s Carvykti has once again demonstrated a major benefit—this time in prolonging patients’ lives.
 

Top Stories

Kezar halts dosing and enrollment in key lupus study after 4 patient deaths

The voluntary hold comes after Kezar restructured last year to in a bid to support its lupus and hepatitis candidate zetomipzomib.

ASTRO: Randomized prostate cancer study finds no major differences between IMRT and proton beam radiation

A prostate cancer trial compared two types of radiation treatments head-to-head, and found both helped control tumors with no differences in quality of life.

Moderna rebuked over second successive Spikevax marketing breach

Moderna has suffered its second PMCPA rebuke in quick succession. Days after ruling Moderna had brought discredit on the industry, the U.K. self-regulatory body reached the same damning conclusion in a separate case.

CDMOs eye industrywide growth in 2025 as many spurn BIOSECURE Act, CPHI research shows

Ahead of the CPHI conference in Milan, the events group has teased new research signaling an expected rebound for the CDMO industry—and a rejection of the BIOSECURE Act.

Roche celebrates Pharma Day by buying Regor's CDK inhibitors, regenerative med-focused AntlerA

Genentech is paying $850 million upfront for Regor Pharmaceuticals’ portfolio of CDK inhibitors, taking ownership of a breast cancer candidate that has shown signs of single-agent efficacy in patients failed by existing options. Roche, Genentech’s parent company, also disclosed the acquisition of AntlerA.

Remedee Labs nabs European approval for fibromyalgia wristband therapy

The company’s millimeter-wave wristband stimulates the release of the endorphins to counteract the chronic condition and provide relief.

Otsuka falls foul of most serious drug marketing breach, again, as Jinarc training site comes under fire

Otsuka is once again on the PMCPA’s naughty list as the U.K. drug marketing regulatory body has for the second time this year found the Japanese pharma guilty of its most serious code breach.

Regulatory tracker: Formycon, Fresenius Kabi notch FDA and EU approvals for their Stelara biosimilar

In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning.

BMS pays $110M to form T-cell therapy pact, helping Prime buy time to advance prioritized pipeline

Bristol Myers Squibb is paying Prime Medicine $110 million upfront to develop reagents for ex vivo T-cell therapies. Prime, which could receive a whopping $3.5 billion in milestones, disclosed the deal alongside details of a pipeline prioritization intended to extend its cash runway into the first half of 2026.

Rivus reveals data to back up muscle-sparing claims of phase 2 obesity drug

Rivus Pharmaceuticals has unveiled the data behind its phase 2 obesity win in heart failure patients, showing that the candidate can indeed help patients reduce weight while they retain muscle.

Bipolar research initiative reveals $18M in grants, opens call for another $18M funding round

A bipolar disorder research initiative backed by Big Tech has announced $36 million in new funding for research into the disease’s biology.
 
Fierce podcasts

Don’t miss an episode

ESMO, WCLC lung cancer data spark hope—and debate

In this week's "The Top Line," Fierce journalists discuss key issues from promising but debated lung cancer data at recent conferences.
 

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Building a “Best Practice” Commercial Organization in Biopharma

We interviewed dozens of biopharma leaders on the critical success factors for building a Best Practice commercial organization. This report shares what we learned.
 

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On Helix

Date: ‌4 ‌July ‌2024 ‌- ‌Location: ‌Babraham ‌Research ‌Campus, ‌Cambridge ‌UK

 

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