News

India's Cipla gets U.S. beachhead with $550M deal for 2 generics operations

India's Cipla has lagged behind its compatriots in challenging U.S. drugmakers on their own turf, currently getting less than 10% of its revenues from the lucrative U.S. market. The company is making moves to change that equation, announcing a small deal on Friday to buy two U.S. focused generics companies.

UPDATED: AstraZeneca scores FDA nod for long-term Brilinta use

AstraZeneca's blood thinner Brilinta is officially one step closer to living up to the British pharma's $3.5 billion ambitions. The FDA has handed down an approval for long-term use of the drug in patients who have previously suffered heart attacks, a label expansion that will keep sales coming beyond the first year of therapy.

Ka-Ching: F. Michael Ball cashes out of Hospira with $91.1M

Early indications that CEO F. Michael Ball would cash out with $80 million when Pfizer completed its buyout of Hospira were clearly off the mark. Instead the golden parachute for the former CEO allowed him to land softly with $91 million and change.

Undeterred by PTO setbacks, Bass slaps new challenges on Acorda patents

Hedge-fund manager Kyle Bass may have hit some recent speed bumps in his quest to challenge pharma patents through a U.S. Patent and Trademark Office review system. But he's not giving up.

Novartis snags EU approval for multiple myeloma med Farydak

Novartis scored EU approval for its multiple myeloma med Farydak (panobinostat), months after the FDA signed off on the drug for patients with serious forms of the disease.

Bayer plots Q4 IPO with an eye on $2.8B

Bayer's plastics unit spinoff is in the works for Q4, sources tell Reuters. At that time, the German company plans to carry out an IPO for the business, to be dubbed Covestro, and it's aiming to raise about E2.5 billion ($2.8 billion).

GSK inks exclusive vaccines deal with new GlycoVaxyn affiliate

When GlaxoSmithKline bought out GlycoVaxyn for $190 million earlier this year, it gained a set of early-stage vaccines and commissioned GlycoVaxyn's team to create a new company around its existing research operation. That company is LimmaTech Biologics, and now, it and GSK have struck a 5-year exclusive agreement to develop novel bioconjugate antigen-based vaccines.

Pharma's new patent worry by the numbers: No 'IP death squad' here, analyst says

With generics makers attacking Teva's next-generation Copaxone and hedge fund manager Kyle Bass waging war on a range of pharma patents, these days, the phrase "inter partes review"--or IPR--is flying around more than ever. But how much do pharma companies need to worry about these patent reviews affecting their IP protection?

Novartis' LCZ696 scores another victory with early-access blessing in U.K.

Novartis won't have to wait for European regulators to do a full-force data sift before its new heart failure drug becomes available in England. The U.K. will allow Novartis to roll out its Entresto drug under an early-access scheme begun last year.

Novartis finally gets to roll out inaugural biosim Zarxio. What will payers and docs do?

The age of biosimilars in the U.S. has finally dawned with the launch of Novartis' Zarxio, a copy of Amgen's Neupogen (filgrastim). And it's arriving with a 15% discount to win scripts over from the brand.

In a bad-news first for pharma reps, more than half of doctors now restrict access

It's no secret that pharma salespeople are barred at the doors of many doctors' offices. Those doors have been closing one by one for several years. But now, more than half of physician practices restrict reps' access--and in some specialties, only one in five doctors are rep-friendly.

UCB hands off U.S. generics business to Lannett for $1.23B

Belgium's UCB has had a tough time unloading its U.S. generic drug business, calling off a sale last year amid regulatory pushback over one of the unit's products. Now the company is closing one chapter and moving on to the next, selling the business to Lannett for $1.23 billion to lighten its load and refocus on high-growth areas.

 

Report: Real-world Blincyto spending likely to fall far short of Amgen's $178K list price

When Amgen rolled out its Blincyto treatment for an ultra-rare form of leukemia, the California biotech set what seemed to be an eye-watering price--$178,000 for a typical patient. But some number-crunching of clinical trial data, coupled with documents from the Centers for Medicare and Medicaid Services, suggests that the real-world cost will be much lower.

Boehringer touts Pradaxa antidote data as FDA decision nears

LONDON--Boehringer Ingelheim's Pradaxa currently trails Johnson & Johnson and Bayer med Xarelto in the market for new-age anticoagulants, but the German drugmaker is hoping a nod for its antidote candidate will help turn the tide in its favor.

More grist for PCSK9 fight as Amgen sets up EU to pay about half as much as U.S.

Last week, Amgen won its much-anticipated FDA approval for the PCSK9 cholesterol-fighter Repatha and promptly set a price of $14,100 per year. But even after pharmacy benefits managers and insurers wring out their discounts, the cost is unlikely to be nearly as low as Repatha's price tag in Europe.

Valeant doubles size of its HQ as deal spree continues

Serial buyer Valeant is expanding quickly, and to keep up, it's expanding its office space, too. The Canadian pharma has leased another 310,000 square feet at Somerset Corporate Center in Bridgewater, NJ, doubling its footprint at the complex less than two years after setting up its U.S. headquarters there, NJBIZ reports.

European pharma lobby says 'non' to French funding for off-label Avastin

The French government recently said "oui" to Roche's ($RHHBY) cancer drug Avastin as a cheap, off-label treatment for the blinding eye disease wet age-related macular degeneration (AMD), prompting a resounding "non" from the pharma industry, which is none-too-pleased with the country's latest move.

Trial set for Pfizer in Protonix Medicaid rebate case it inherited

A federal judge's inclination means Pfizer could remain in the line of fire to pay out more than $2 billion. That is the potential liability Pfizer faces for a federal lawsuit accusing its Wyeth unit of failing to pay Medicaid rebates for stomach upset drug Protonix.

BMS, AbbVie nab 'breakthrough' tag for multiple myeloma-fighting antibody

A new drug for blood cancer from Bristol-Myers Squibb and AbbVie is on the fast track to FDA approval, winning a priority review to treat multiple myeloma.

Bernie Sanders proposes raft of legislation to combat rising drug prices

Sen. Bernie Sanders, a longtime pharma watchdog, says he's rolling out legislation to stall drug price hikes. The presidential candidate's proposals include some previously failed measures--including Medicare price negotiations--but they come at a time when public debate about the rising cost of meds has reached a fever pitch.