AZ, Merck's Lynparza adds new use

Today's Big News

Jun 1, 2023

Look out, GSK. Pfizer has its adult RSV vaccine approval and is raring to launch


Eikon snaps up clinical pipeline thanks to 'buyer's market,' while internal pipeline remains covert


AZ, Merck's Lynparza wins FDA nod in prostate cancer subgroup following advisory committee vote


Labcorp launches liquid biopsy to detect cancer-related biomarkers


Novartis buys priority review voucher from Pharming for discount price of $21M

 

Featured

Look out, GSK. Pfizer has its adult RSV vaccine approval and is raring to launch

After winning FDA approvals one month apart, Pfizer and GSK are set to launch competing RSV vaccines this fall.
12-14
Jun
San Diego, CA
 

Top Stories

Eikon snaps up clinical pipeline thanks to 'buyer's market,' while internal pipeline remains covert

Eikon Therapeutics has added three clinical-stage candidates and a suite of preclinical assets to its portfolio after raising more than $600 million since launching.

AZ, Merck's Lynparza wins FDA nod in prostate cancer subgroup following advisory committee vote

The drug is now approved to treat BRCA-mutated metastatic castration-resistant prostate cancer in combination with Johnson & Johnson’s Zytiga and a corticosteroid. The FDA nod comes after a committee of independent experts voted in favor of the limited approval.

Labcorp launches liquid biopsy to detect cancer-related biomarkers

A new blood test from Labcorp could potentially help cancer patients begin the most efficient treatments as early as possible.

Novartis buys priority review voucher from Pharming for discount price of $21M

Novartis has acquired a priority review voucher from Pharming for the bargain price of $21.1 million, thanks to some canny dealmaking dating back a few years.

Medicare to broaden coverage of Alzheimer’s drugs after full FDA approval, but with some restrictions

CMS reiterated its plans Thursday to broadly cover a new class of Alzheimer’s drugs once the medications get full approval from the Food and Drug Administration. 

Getinge offers $290M for single-use bioprocessing equipment maker

In its second acquisition of 2023—and its largest in several years—Swedish devicemaker Getinge has set its sights on High Purity New England, which churns out a range of products used throughout the drug discovery and development processes.

AstraZeneca drops Skyrizi rival after seeing R&D timeline spiral

AstraZeneca is abandoning a play for the inflammatory bowel disease market. After seeing clinical trial timelines spiral, the Anglo-Swedish drugmaker has stopped development of a would-be rival to products sold by AbbVie and Johnson & Johnson.

Former Novartis execs cleared of Greek bribery charges after yearslong investigation

After an investigation that dates back to 2017, four former Novartis executives and a Greek politician were cleared of bribery charges. But 15 doctors were charged for their alleged involvement.
 
Fierce podcasts

Don't miss an episode

'The Top Line': Most influential people, plus the headlines

This week on "The Top Line," we discuss the 20 most influential people in biopharma, plus a topical gene therapy, a new opioid overdose medication, and the rest of the week's headlines.

 

Resources

eBook

Strategies to Optimize Clinical Trial Enrollment Timelines

See how clinical trial sponsors can build stronger strategies to address challenges across the patient enrollment funnel, starting with four necessary steps.
Whitepaper

Commercializing Gene Therapies, Part 4 – Market Entry

This paper outlines various market archetypes and key considerations leaders must address when prioritizing new potential markets for gene therapies.
Whitepaper

ChatGPT in Drug Discovery: Rise of Large Language Models

ChatGPT shows promise in drug discovery for information extraction, scientific text authoring, hypothesis prediction, and chemical entity prediction. This whitepaper explores its potential to streamline research, delving into its technology, applications, and limitations.
Whitepaper

Discovering High-Affinity, Functional Anti-GLP-1R Antibodies

Learn how a GPCR-focused library with a cell-based biopanning strategy led to the discovery of 13 high-affinity and selective anti-GLP-1R antibodies with highly developable therapeutic properties.
Research

How Lilly’s Legal and Library Services Empower Teams Across the Drug Development Pipeline

What role do the Library and Legal teams play in the drug development pipeline at Lilly? An import one – find out how.
Whitepaper

Medical Affairs Metamorphosis VI: The Changing Face of Stakeholder Engagement

This paper focuses on stakeholder engagement and how Medical Affairs teams’ responsibilities, goals, tools, and techniques are changing.
Research

Maximizing Clinical Trial Success

Strategies for Optimal Site Selection and Feasibility Research in Novel Therapies and Geographies
Whitepaper

Running Decentralized Trials at Scale

Explore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment.
Whitepaper

Designing an Optimal APAC Clinical Supply Chain

Discover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific.
Whitepaper

Key Clinical Supply Issues Sponsors Should Consider with their CRO

As sponsors increasingly look to CROs to support their clinical studies, making and addressing certain clinical supply considerations at the outset of the relationship can reduce the risk of potentially unforeseen impact to budget and time later. Discover key issues sponsors should consider to help their CRO or partner of choice better understand their clinical supply needs.

Whitepaper

Specialized Expertise for Management of Clinical Supply Budgets

For sponsors, cost is a key concern when it comes to managing the supply of their clinical trials. A financial project analyst (FPA) is a specialized expert who can help control clinical supply costs and keep the project within budget. Explore the critical role that a Financial Project Analyst plays in clinical trial supply and budget management.
Whitepaper

Clinical Supply Solutions for the Asia-Pacific Region

Learn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region.
Whitepaper

Roles and Responsibilities of Specialized Clinical Supply Experts

How can specialized expertise help you optimize your clinical supply chain? Learn about the roles and responsibilities of unique experts such as clinical supply management, project management, and financial project analysis.
Whitepaper

Questions You Need to Ask Your CRO About Clinical Supply

Planning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial.
Whitepaper

Supply Services to Support Clinical Trials in Japan & Beyond

Explore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world.
 

Industry Events

 

Upcoming Fierce Events

12-14
Jun
San Diego, CA
13
Jun
Free Virtual Event
20-22
Jun
Free Virtual Event
22
Jun
Free Virtual Event
18-19
Jul
July 18-19, 2023 | Jersey City, NJ

View all events