Biogen and Samsung's Enbrel biosimilar wins EMA nod for EU approval

Enbrel is one of the world's best-selling drugs with nearly $9 billion in global sales last year shared by Pfizer in Europe and Amgen in the U.S. But competition is hot on its heels in the guise of biosimilars. And in the newest attack, a copycat version of the anti-TNF med from Biogen and Samsung has been recommended for approval in Europe.

Merck KGaA rolls out big plans for expansion in Africa

Merck KGaA has been turning to emerging markets to deliver a much-needed boost to business, targeting China and Latin America as areas ripe for growth. Now the German pharma is turning its sails toward Africa, planning to expand its presence on the continent over the next 5 years as part of its comeback story.

Dr. Reddy's strikes back at AstraZeneca in purple pill courtroom battle

AstraZeneca has been duking it out with Dr. Reddy's Laboratories over generic Nexium, winning a round last week after a Delaware district judge put the kibosh on sales of Dr. Reddy's generics and said that Nexium's distinctive purple hue protected it from copycat competitors. But Dr. Reddy's isn't going down without a fight.

UPDATED: Pfizer prepared to risk a 3% breakup fee for chance at Allergan, sources tell Reuters

Breaking up can be hard to do. It can also be expensive, which would be the case for Pfizer if the roughly $150 billion deal it is reportedly negotiating with Allergan were to go south. But the potential cost is a sum that Pfizer is reportedly willing to wager as it tries to outrun changes in the U.S. tax code that would make the kind of tax-inversion deal it is negotiating unpalatable.

'Pfizergan' talks prompt new anti-tax inversion rules from Treasury

The U.S. Treasury Department is rushing out a new set of guidelines on the "tax inversion" deals that have allowed drugmakers to save big money on taxes by buying overseas rivals and moving their domiciles to friendlier jurisdictions.

Pfizer, Allergan in final talks for all-stock deal worth a record-breaking $150B

Pfizer and Allergan are coming down to the wire on a merger that would be the biggest pharma deal ever. The all-stock transaction would be worth up to $150 billion, at a price of $370 to $380 per share, according to media reports, though analysts have estimated a per-share price of up to $400.

Mallinckrodt boosts buyback plan amid news of a 2,000% price hike on infant drug

Mallinckrodt's shares have suffered since short seller Citron Research called out the company's pricing policies and marketing efforts last week. A newly disclosed price hike set off a storm of criticism earlier this week. Now, the company is seeking to gin up shareholder support with a $500 million boost to its stock-buyback program.

Post-AASLD, Gilead's lead in hep C looks as solid as ever: Analysts

Analysts handicapping the competitors in hepatitis C, current and future, say Gilead Sciences is likely to continue dominating the field, though it might cede some niches to newer rivals.

Express Scripts rolls out value-based pricing for cancer meds

Express Scripts will put its money behind a new value-based reimbursement model next year, using comparative data and indication-specific pricing to favor "clinically superior" meds. The pharmacy benefits manager will roll out the approach in cancer first, with anti-inflammatory meds close behind.

Adapt's new bargain-priced OD antidote enters contentious market

The rising number of opioid-related deaths in the U.S. has translated into big opportunity for pharma companies making the antidote med naloxone, with drugmakers such as Amphastar Pharmaceuticals getting a sizable boost in revenue amid growing demand for its products. But Amphastar could soon face more competition, as the FDA has granted quick approval for a nasal spray opioid antidote that runs at a lower price than injectable treatments and promises increased benefits for caretakers.

Pfizer close to record-breaking Allergan deal at up to $380 per share: Bloomberg

Pfizer and Allergan are close to striking a deal that would be the biggest of 2015 by far--and the biggest healthcare deal ever, Bloomberg reports. The price: $370 to $380 per share, or almost $150 billion.

Millennial men lead the charge in seeking info from pharma marketing

Men have pharma needs, too. Traditional pharma marketing strategies target women, following common marketing wisdom that women control or influence the vast majority of household purchases, up to 80% or more depending on which study you read. But new research from ID Media points to men taking a more active role in healthcare. 

Shortages, soaring generic injectable drug prices leave hospitals scrambling

Hospital pharmacy folk understand supply and demand and realize that when there is a shortage of the generic injectables drugs they routinely use, a big price hike is coming. What they don't get is why when another supplier jumps into the market, prices come down little, if any.

Allergan demands CEO slot for Saunders as condition for Pfizer buyout: Forbes

If Pfizer does make a friendly deal for Allergan, CEO Ian Read will be giving up his seat at the helm. That's the word from sources at Pfizer, who told Forbes' John LaMattina that current negotiations depend on Allergan CEO Brent Saunders taking charge at the combined company.

U.K. cost gatekeeper says 'no' to Amgen's PCSK9 cholesterol fighter Repatha

Amgen got a thumbs-down from U.K. cost watchdog the National Institute for Health and Care Excellence (NICE) for its PCSK9 cholesterol-fighter Repatha (evolocumab), bad news for the drug as it contends with pricing pushback and competes head-to-head with Sanofi and Regeneron's Praluent for market share.

Advera Health: Novartis, GSK asthma meds linked to more side effects than Merck drugs

Bestselling asthma drugs from Novartis and respiratory behemoth GlaxoSmithKline are also showing more adverse events in post-marketing safety data than competing products from Merck, according to a new report, potentially presenting issues further down the line as companies duke it out for market share.

Cancer, hep C and other specialty meds to drive global drug market to $1.4T by 2020

Drug spending is on the rise, according to a new report from the IMS Institute of Healthcare Informatics. Total global spending on pharma products is expected to shoot up to $1.4 trillion by 2020, a 29-32% leap--or $349 billion increase--from 2015, the company said.

Bristol-Myers nabs FDA priority review for new Opdivo use in kidney cancer

The FDA put Bristol-Myers Squibb's immuno-oncology drug Opdivo on its priority review fast track for a new use in kidney cancer. It would be yet another new indication for Opdivo, which was first approved for melanoma last year and now boasts two indications in lung cancer. 

Pharma faces 'challenging and prolonged' reforms in China, with pricing power at risk

Big Pharma has already seen sales in China slow, thanks in part to stepped-up competition from local drugmakers. Healthcare reform there is also taking its toll. But Fitch Ratings says pharma's troubles in China are only beginning.

AstraZeneca stokes Tagrisso's blockbuster hopes with $12,750-per-month sticker

AstraZeneca unveiled its pricing plan for the new targeted lung cancer pill Tagrisso that won early FDA approval Friday: $12,750 per month, or $153,000 for a full year of treatment. That's on par with other targeted cancer pills, including the company's own Iressa, a spokeswoman tells Reuters.