The Latest
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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 -
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 -
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 -
SponsoredWith EngagedMedia, Aptus Health set to scale up patient adherence
As digital technologies rapidly transform the relationships between patients and pharmaceutical companies, Aptus Health adds a mobile-first, data-driven platform to its portfolio.
Mergers and Acquisitions / Deals -
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.
Corporate News -
Entasis optimistic on safety trial results for UTI drug
Both the privately-held biotech's treatment and placebo achieved 100% clinical success in the Phase 2 trial.
Clinical Trials -
Realm Therapeutics faces another Phase 2 failure in eczema
The small biotech saw its only clinical trial fail, leaving its stock tattered and execs with a murky path forward.
Clinical Trials -
Icahn raises white flag in Cigna-Express Scripts tiff
Activist investor Carl Icahn relinquished his fight to block Cigna's acquisition efforts after two high-profile advisory firms backed the deal.
Mergers and Acquisitions / Deals -
FDA OKs marketing of contraceptive app
The Natural Cycles app has generated controversy in Europe, where women have reported unplanned pregnancies while using it.
Regulatory / Compliance -
Regeneron quickly clears up 12-week Eylea CRL
Regulators rejected Eylea amid "ongoing labeling discussions" with Regeneron, yet an approval four days later suggests the problems were easily solved.
UPDATED: Aug. 17, 2018 at 11:16 a.m.
Regulatory / Compliance -
Drugmakers say R&D spending hit record in 2017
The industry estimate of its own spending comes amid heightened political and public angst over drug prices.
Corporate News -
SponsoredIf this part-time CEO will be the face of the effort, who will be the muscle?
Bezos, Buffet and Dimon Bring in CEO Gawande for their healthcare venture: Who Will Be the Muscle?
Corporate News -
In first, FDA approves RNA interference drug from Alnylam
Alnylam's drug, called Onpattro, will carry an average annual list price of $450,000, although the biotech expects rebates to bring the net price down by a fifth.
UPDATED: Aug. 10, 2018 at 4:13 p.m.
Regulatory / Compliance -
Amicus secures US approval for Fabry disease drug
It's an outcome that looked to be in question when the FDA asked for more data two years ago. But an agency reversal cleared the way for Amicus to move forward.
UPDATED: Aug. 13, 2018 at 10:23 a.m.
Regulatory / Compliance