EuroPharma Today

Lack of Cladribine Answers And Dividend Cut Cloud Merck KGaA’s Outlook

Two questions dominated Merck KGaA's earnings call on Feb. 23 - how was the company addressing last December's refuse-to-file notice from the U.S. FDA for oral cladribine in multiple sclerosis? And why was the company cutting its dividend?

But neither question was answered completely to analysts' satisfaction. Meanwhile, the German company's stock fell by 10 percent on the day to €58, a six-month low.

Basilea Recovers With Astellas Deal For Phase III Anti-Fungal Following J&J Break-Up

Switzerland's Basilea licensed its Phase III anti-fungal isavuconazole to Japan's Astellas Pharma Feb. 24, just days after Johnson & Johnson revealed it was pulling out of its five-year deal with the biotech on the delayed antibiotic ceftobiprole.

Top Pharma Dealmakers To Gather in Paris

Are you looking to grow your biopharma business through financing, M&A or stratgic partnerships?

Switzerland's Basilea Regains Full Rights from J&J to Ceftobiprole

J&J's decision to hand back full rights to ceftobiprole to its partner, the Swiss biotech Basilea, and back out of their five-year-old alliance will end a tortuous regulatory story for both partners.

EU Regulator Wants Closer Ties With Health Technology Assessors

LONDON - Among the proposals in the European Medicines Agency's five-year strategy document, the "Road Map to 2015", is a call for closer ties with health technology assessment (HTA) bodies like the UK National Institute for health and Clinical Excellence (NICE).

Euro Deals of the Week

Last week saw a couple of interesting deals by European-based Big Pharma--including Sanofi Aventis' very nationally-focused academic tie-up--small dollars, but high symbolism, perhaps--and AstraZeneca's latest upfront-cash-heavy in-licensing deal with Rigel for a Phase II oral RA candidate.

Ireland Cuts Drug Prices And May Also Introduce Reference Pricing

Ireland slashed the prices of 300 branded multisource medicines, including Zofran and Casodex , by around 40 percent at the start of the month, and there are strong indications that more cutbacks are to follow, with reference pricing and generic substitution as distinct possibilities.

U.K. NICE Snubs Novo's Victoza, But Drug Launches Fast In The U.S.

The U.K.'s cost-effectiveness watchdog, the National Institute of Clinical Excellence, issued draft guidance on Feb. 15 recommending only limited reimbursement for Novo Nordisk's newly-launched diabetes drug Victoza (liraglutide), despite the GLP-1 analog's proven efficacy not only in lowering blood sugar, but also in promoting weight loss.

On the bright side for Novo: a very rapid U.S. launch means the drug is now available in 90 percent of U.S. pharmacies, just three weeks after its delayed approval by FDA (¹ 'The Pink Sheet' DAILY, Jan 26, 2010).

Will IT Firms Displace Pharma in Health Care Collaborations?

LONDON--Will pharmaceutical companies lose control of the delivery of health care to upstart telecoms or even computer game manufacturers?  Patrick Flochel, a Life Sciences Leader at Ernst & Young, thinks the signs may already be pointing in that direction.

Bioequivalence Guideline From EMEA Focuses On Quality, Not Clinical, Issues

The European Medicines Agency has released a simplified version of its guideline on bioequivalence that focuses on quality issues, instead of clinical efficacy and safety perspectives.