plc, of Dublin, Ireland, published a response to an offer made by Echo Pharma Acquisition Ltd. (Royalty Pharma) on May 2...Helsinn Healthcare SA, of Lugano, Switzerland, and Vifor Pharma, of Villars-sur-Glane, Switzerland, signed an exclusive license and distribution agreement for netupitant-palonosetron fixed-dose combination, an investigational Helsinn product for chemotherapy-induced nausea and vomiting, giving rights to Vifor to distribute the product in Switzerland, France, Spain, Portugal

Quintiles will also contribute to Merck Serono's future trial design process

Common stock in Fibrocell Science Inc., of Exton, Pa., has been approved for listing on the NYSE Market, to commence trading on May 17, under the ticker symbol FCSC...The product is marketed by Genentech Inc., a member of the Basel, Switzerland-based Roche Group, and Astellas Pharma Inc., of Tokyo...Genfit SA, of Lille, France, said GFT505 reduced a new component of cardiovascular risk, remnant cholesterol, contained in lipid particles other than LDL and HDL

Janssen Research & Development LLC, of Raritan, N.J., a unit of Johnson & Johnson, said the FDA granted priority review to its new drug application for simeprevir (TMC435), an NS3/4A protease inhibitor for once-daily administration with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease...Valeant Pharmaceuticals International Inc., of Laval, Quebec, has provided additional information related to the proposal to continue

The big pharma said no agreement has been reached and it does not intend to issue further comments...We note that an acquisition of Warner could potentially offer a tax strategy as Warner has a lower tax rate

Acceleron Pharma Inc., of Cambridge, Mass., said preclinical research conducted by Acceleron scientists on the ACE-536 program were presented at the 12th International Symposium on Myelodysplastic Syndromes in Berlin...Zhejiang Beta Pharma will own 51 percent of it and Amgen will own the remaining 49 percent...The split is intended to increase the per-share trading price of the common stock to satisfy the $1 minimum bid price requirement for continued listing on the Nasdaq Capital Market

Under the terms, Adaptive will use its immune profiling assay, immunoSEQ, to identify potential biomarkers that may inform about drug response

Merck expects the review for this BLA, as well as a BLA for its Timothy grass pollen (Phleum pretense) sublingual allergy immunotherapy tablet, to be completed in the first half of 2014

Eisai Inc., of Woodcliff Lake, N.J., said the European Commission granted orphan drug designation to multityrosine kinase inhibitor lenvatinib for the treatment of follicular and papillary thyroid cancer...In separate news, Eisai said it filed a Type II variation application with the European Medicines Agency for Halaven (eribuln), requesting an indication extension to include treatment of earlier-line metastatic breast cancer patients

In other news, Addex said dipraglurant demonstrated dose-dependent mGlu5 receptor occupancy in a nonhuman primate positron emission tomography study, showing the correlation between the plasma concentration of dipraglurant and occupancy of dipraglurant on mGlu5 receptors in the brain...Moberg Derma AB, of Stockholm, Sweden, said the Swedish Companies Registration Office granted the firm's application for a name change to Moberg Pharma AB

Bristol-Myers Squibb Co., of New York, said the FDA approved a supplemental new drug application for the HIV-1 therapy Sustiva (efavirenz), including dosing recommendations for HIV-1 infected pediatric patients three months to three years old and weighing at least 3.5 kg...Inc., of Whitehouse Station, N.J., said the FDA has approved Liptruzet (ezetimibe and atorvastatin) tablets to treat elevated low-density lipoprotein cholesterol in patients with primary or mixed hyperlipidemia as adjunctive

ChemRar Ventures, of Moscow, said it signed a scouting agreement, for a period of 18 months, with Sanofi SA to source a venture investment in Russia...In granting the motion, the judge ruled that the plaintiffs failed to offer any reliable evidence that Mr. Cooper's disease was caused by Actos (pioglitazone HC1)," said Kenneth D. Greisman, senior vice president, general counsel, Takeda Pharmaceuticals U.S.A. Inc...Actos is prescribed for use with diet and exercise to improve blood sugar control in

In separate news, Hyperion said it exercised its option to acquire Buphenyl (sodium phenylbutyrate) tablets and powder, an FDA-approved therapy for the chronic management of the most prevalent UCDs, and Ammonul (sodium phenylacetate and sodium benzoate) injection, a hospital-based product used to treat UCD patients in hyperammonemic crisis, from Valeant Pharmaceuticals International Inc., of Montreal...The big pharma firm stated that it has opted to prioritize the fixed-ratio combination of Lantus

It's the second oncology compound within the Janssen pipeline to receive the designation in the last three months...The company expects to repurchase about $7.5 billion of common stock over the next 12 months, financed through a combination of debt issuance and operating cash flows, with the remainder to be repurchased over time with no time limit

Like plasma, Kcentra is used in conjunction with the administration of vitamin K to reverse the anticoagulation effect and stop the bleeding...NextBio, of Santa Clara, Calif., said it inked a multiyear collaboration with Paris-based Sanofi SA aimed at using NextBio Clinical to incorporate patient omics and clinical data into Sanofi's drug R&D, as part of the big pharma's Translational Medicine for Patients program

Addex Therapeutics SA, of Geneva, said regulatory authorities in the Netherlands gave approval to start in the first half of this year a Phase I study of ADX71441, a GABA-B receptor positive allosteric modulator, for Charcot-Marie-Tooth1A (CMT1A) neuropathy and other disease indications...for the Brisbane, Australia-based company's Diversity Scanning Array (DSA) and Versatile Assembly on Stable Templates (VAST) technologies in a deal worth up to $240 million in milestones, plus other payments

to formulate CytoDyn's PRO 140 bulk drug substance through a fill-and-finish process for clinical-ready vials to advance two National Institutes of Health (NIH)-funded Phase IIb studies...Pfenex Inc., of San Diego, awarded Glide Pharma, of Oxford, UK, a subcontract to develop a solid formulation containing the recombinant protective antigen (rPA) from Bacillus anthracis expressed in Pfenex Expression Technology, suitable for delivery with the Glide SDI (solid dose injector

Merck will continue to retain rights to its existing portfolio of sitagliptin-containing products...The first suit pertains to a previously disclosed investigation into discounts and rebates to specialty pharmacies for Myfortic

Novartis has worldwide rights to the drug, along with certain backup compounds in all indications, with Incyte retaining a co-development option to INC280 in the U.S...Due to third-party manufacturing issues, distribution of Janssen Products LP's Caelyx in Europe has been intermittently disrupted since 2011