The Latest
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5 questions on the Trump admin's bid to mandate prices in drug ads
Pharma, which spends billions each year to advertise its products on television, is expected to fiercely oppose the proposal.
Marketing -
SponsoredSix practices of high performing clinical research sites
How are high-performing clinical research sites getting sponsors to return to them again and again?
Clinical Trials -
An early approval puts Pfizer's Talzenna in a crowded field
Pfizer picked up the PARP inhibitor in its $14 billion deal for Medivation two years ago. Talzenna will join three other drugs on market that work similarly.
Marketing -
Amgen launches TV spot for Aimovig in tight CGRP market
The campaign comes days after the Trump administration proposed mandating disclosure of list prices in prescription drug ads.
Marketing -
Biosimilars bite into Herceptin in Europe
Yet Roche sustained growth thanks to fast uptake of new drugs like Ocrevus. Next year could prove a tougher test, when biosimilars enter in the U.S.
Marketing -
J&J sees 'evolution in pricing, not a revolution' in 2019
"I think we just need to be careful; things such as list price alone [are] not the full extent of the information," said J&J's pharma unit chief on a Tuesday call.
Marketing -
7 drugmakers to watch on Q3 earnings
M&A has cooled down, but other major themes like drug pricing, biosimilars and restructurings should feature during third quarter earnings season.
Corporate News -
Confronting pharma, Trump admin seeks price disclosure in drug ads
HHS chief Alex Azar announced the much-anticipated proposal Monday, dismissing a new pledge from trade lobby PhRMA as insufficient.
UPDATED: Oct. 15, 2018 at 6:33 p.m.
Marketing -
Roche's Kadcyla beats out Herceptin in Phase 3
The data should help to advance the Swiss pharma's plans to reinforce its breast cancer franchise as biosimilar competition to Herceptin creeps in.
Clinical Trials -
Under pressure, drugmakers give an inch on DTC drug ads
Members of the trade group PhRMA will soon point consumers to drug cost information in direct-to-consumer TV ads, but won't go so far as to include prices upfront.
UPDATED: Oct. 15, 2018 at 1:04 p.m.
Marketing -
J&J snaps up key label expansion for Xarelto
Regulators cleared the drug to reduce the risk of major cardiovascular events for certain patients, which could help its position against market leading Eliquis.
Marketing -
Alnylam nixes accelerated approval plans for givosiran, pushing back timeline
The biotech will begin a rolling filing to the FDA this year, but doesn't anticipate completing submission of the RNAi therapy until the middle of next year.
Clinical Trials -
Mylan's generic Copaxone wins in court, but market barriers remain
A court of appeals confirmed Teva's patents for the blockbuster multiple sclerosis drug are invalid, in turn strengthening Mylan's hand.
Marketing -
Opdivo misses survival goal in small-cell lung cancer study
The clinical setback could weigh on Bristol-Myers' chances of staying competitive in the less common lung cancer type.
Clinical Trials -
With latest deal, AbbVie keeps another Humira biosimilar at bay
An agreement with Novartis allows for the Swiss pharma's copycat version to launch in the U.S. in September 2023, behind rivals from Amgen and others.
Marketing -
Merck, Samsung Bioepis end development on copy of Sanofi's Lantus
Merck will pay its Korea-based partner a $155 million termination fee. The companies said other biosimilars they are developing together are not affected.
Drug Discovery -
Trevena's opioid gets thumbs down from FDA adcomm
While the FDA doesn't have to follow the advice of the panel, the negative vote doesn't bode well for the fate of oliceridine.
Clinical Trials -
FDA sets another record in 2018 for generic drug approvals
Approvals climbed higher for the second consecutive year, as the agency has prioritized approving copycat drugs to boost competition.
Regulatory / Compliance -
Gilenya beats Copaxone head-to-head at higher dose, study finds
The multiple sclerosis drugs are top-sellers for their respective makers, Novartis and Teva. Yet a Phase 3b trial showed an efficacy edge for Gilenya.
Clinical Trials -
US tightens scrutiny of foreign investment into biotech sector
New rules put in place by the Treasury Department would expand review of foreign investments in biotechnology R&D and 26 other critical industries.
Regulatory / Compliance -
Trump signs law allowing FTC to scrutinize biosimilar deals
A former FTC lawyer said the new law, which also deals with pharmacy gag clauses, will clarify the commission's authority to routinely review such deals.
UPDATED: Oct. 10, 2018 at 2:17 p.m.
Regulatory / Compliance -
FDA clears Vertex, CRISPR to test gene-editing therapy in sickle cell patients
With a clinical hold dating back to May resolved, the companies said they plan to start a Phase 1/2 study of CTX001 in the U.S. by year's end.
Clinical Trials -
As clock ticks, EMA launches 3rd phase of Brexit plan
The agency has started to scale back non-urgent activities as its move to Amsterdam draws closer.
Clinical Trials -
Expansion gives Almac room to grow in North Carolina
The CDMO opened a fourth building at its Durham campus, with space to add more than 100 employees over the next three years.
Manufacturing -
DOJ clears CVS-Aetna union
Approval of the $69 billion deal comes with a condition to sell Aetna's Medicare Part D business.
Mergers and Acquisitions / Deals