The Latest
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Two Chinese biotechs sign $350M+ PD-L1 inhibitor deal
Kelun-Biotech and Harbour BioMed join the wave of companies vying to enter the checkpoint inhibitor market.
Mergers and Acquisitions / Deals -
SponsoredSeven deadly sins of trial supply management: Is penny-pinching worth it?
Supply chain logistics can make or break a clinical trial. In many cases, failure to provide and manage trial supplies on time has resulted in costly delays. So how does a CRO partner work with a sponsor to ensure supplies are properly managed?
Clinical Trials -
Eisai-Merck partnership picks up first-line Lenvima approval
While Keytruda combo trials remain in progress, the companies secured an important OK for the kinase inhibitor in hepatocellular carcinoma.
Clinical Trials -
Regeneron, Teva boast positive Phase 3 results for osteoarthritis drug
Data showed significant improvements in pain and function, although safety worries for the anti-NGF drug class have tempered expectations.
Clinical Trials -
Trump seeks federal opioid lawsuit, DOJ aims to slash manufacturing quotas
The president said he'd like Attorney General Jeff Sessions to launch a federal suit in addition to ongoing state legal actions. Meanwhile, the DOJ and DEA proposed further cuts to quotas on opioids for 2019.
Regulatory / Compliance -
In pursuit of new insulins, Novo may drop more than $800M on Ziylo
Pricing pressures and competition have pushed diabetes drugmakers to innovate. Novo's looking to do just that in buying the University of Bristol spinout and its glucose-binding molecules.
Mergers and Acquisitions / Deals -
Opdivo gets speedy approval in 3rd-line small cell lung cancer
Though Bristol-Myers' drug is breaking into a less competitive market, it may soon run into trouble there from the likes of Tecentriq and Keytruda.
Marketing -
Q&AAfter a hiring blitz, where is Mustang's CAR-T manufacturing headed?
On the heels of a new plant opening and licensing deal, Chief Technology Officer Knut Niss discussed lessons learned and the road ahead for Mustang.
Manufacturing -
Teva granted FDA approval for first EpiPen generic
It's the latest blow to Mylan, which came under fire for hiking EpiPen's price over the last decade and is now facing manufacturing challenges for the flagship product.
Marketing -
Roche's Genentech planning to lay off 223 employees
Genentech already cut 365 total workers last November and now plans to eliminate hundreds more as Roche braces for biosimilars to erode some of its top brands.
Manufacturing -
US agencies pitch efforts to spur gene therapy development
The chiefs of the FDA and NIH laid out proposals in a New England Journal of Medicine editorial aimed at pushing forward advances in the expanding field.
Regulatory / Compliance -
Fewer worries for Biohaven as it reports positive anxiety data
The biotech's sublingual riluzole hit a Phase 2/3 trial's primary endpoint on social anxiety disorder and public speaking anxiety.
Clinical Trials -
FDA sends Apotex warning letter for Indian manufacturing violations
Another warning heads out to an Indian facility in what is becoming a bumper year for Asian manufacturing violations.
Manufacturing -
Sun Pharma receives FDA approval for dry eye drug
Cequa's thumbs up continues a relatively positive year for the Indian pharma as it now dives deeper into the complex yet profitable ophthalmology market.
Marketing -
Pfizer puts up $425M in flu vaccines deal
A new research collaboration between the big pharma and Germany's BioNTech focuses on creating mRNA-based vaccines for preventing influenza.
Drug Discovery -
CVS adopts ICER metrics in shift to value-based drug pricing
The move also helps CVS counter the narrative that PBMs are to blame for exorbitant drug pricing.
Marketing -
Vertex's Kalydeco first CF drug cleared for infants
The biotech's hold on the cystic fibrosis market has grown tighter with more drug approvals and label expansions.
Marketing -
Catalyst gives positive hemophilia update as 2 more subjects complete study
Consistent with the first patient, all three who have wraped up the Phase 2/3 trial of MarzAA have yet to exhibit bleeding or develop anti-drug antibodies.
Clinical Trials -
Mylan's EpiPen supply woes drag on
In the midst of a strategic review, Mylan is still having problems with EpiPen supplies. The new approval of Teva's generic only makes the situation even more dire.
Manufacturing -
J&J, ViiV tout positive data for two-drug HIV therapy
The ATLAS study provides even more evidence to back up the two-drug approach to HIV.
Clinical Trials -
New York sues Purdue over opioid marketing
Purdue kept up deceptive marketing tactics even after executive guilty pleas in 2007 and an agreement with the state to stop in 2015, the lawsuit claims.
Marketing -
Biogen's Spinraza gets an early no-go from NICE
While noting Spinraza's efficacy in the clinic, the U.K. agency concluded it wasn't a cost-effective use of National Health Service resources.
Regulatory / Compliance -
With Mylan reeling, Kaléo touts its EpiPen rival for back-to-school season
Manufacturing delays at a Pfizer-owned EpiPen plant have created an opportunity for Kaléo.
Manufacturing -
Catalent completes $130M acquisition of Juniper
The deal is the latest in the CDMO space aimed at beefing up services for pharmaceutical companies.
Mergers and Acquisitions / Deals -
Mylan launches generic of United Therapeutics' Adcirca
The commercialization cuts into a major revenue stream for United, while Mylan reaps the benefits of bringing a first generic to market.
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