BIO's Special 301 Submission encouraged the USTR to perform out-of-cycle reviews of patent systems in these countries. (See BioWorld Today, April 2, 2013...The company said it plans to file an investigational new drug application for ES414 next year...The team designed the vaccine to elicit antibodies against not only heroin, but also 6-acetylmorphine and morphine

Janssen Research & Development LLC, of Raritan, N.J., a unit of Johnson & Johnson, said the FDA granted a breakthrough therapy designation for daratumumab for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and IMiD...The company expects to repurchase about $7.5 billion of common stock over the next 12 months, financed through a

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...The goal is to validate emerging epigenetic targets for oncology indications and to demonstrate the eligibility of selected target families for drug formalations

Celgene Corp., of Summit, N.J., said the European Committee for Medicinal Products for Human Use adopted a positive opinion for Revlimid (lenalidomide) for the treatment of patients with transfusion-dependent anemia due to low or intermediate-1 risk myelodsyplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate...The other company, Theravance Biopharma, will be a biopharmaceutical company focused on discovery

flutemetamol to help select patients for a Phase I trial testing Eisai's E2609, a BACE inhibitor for the potential treatment of Alzheimer's disease...Lambrolizumab is Merck's investigational antibody therapy targeting programmed death receptor that is currently being evaluated for the treatment of patients with advanced melanoma, and other tumor types...The Antimonopoly Committee of Ukraine gave approval to Valeant Pharmaceuticals International Inc., of Laval, Quebec, for its proposed acquisition of

Addex Therapeutics, 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...The company expects to deliver safety, pharmacokinetic and biomarker data by the end of the year...Those and other data were presented at the European Association for the Study of the Liver meeting in Amsterdam, the

Charleston Laboratories Inc., of Charleston, S.C., said the FDA granted its request for a pre-investigational new drug application meeting to discuss CL-H1T as a treatment for patients who suffer from migraine pain and migraine-induced nausea or vomiting

Merck currently markets Noxafil oral suspension for prophylaxis of invasive Aspergillus and Candida infections in patients, 13 and older, at high risk of developing those infections due to being severely immunocompromised...PeptiDream Inc., of Tokyo, and Ipsen SA, of Paris, entered a research collaboration and license option agreement to discover, evaluate, potentially develop and launch therapeutic peptides to treat serious medical conditions in areas of therapeutic focus for Ipsen

DART will have the option to select a certain number of candidates for additional development...Other candidates currently undergoing tests required for investigational new drug applications with the FDA include an undisclosed iBioLaunch-produced monoclonal antibody and vaccines for anthrax, malaria and yellow fever...The agreement aims to identify inhibitors of a kinase that plays a key role in tissue protection and repair

Pursuant to the terms, each of the company's ordinary shares, including shares represented by American depositary shares (ADS), will be cancelled in exchange for the right to receive $2.20 in each per share, or $15.40 per ADS...Due to the oversubscription, the closing unit price was set at NIS3.544 per unit

Celgene expects Revlimid to be available to patients late in the second quarter of 2013...Teva opted to make a one-time payment of $880,000 in lieu of future payments

Under the deal, Orexo granted AstraZeneca rights to conduct further preclinical research and evaluate compounds in the OX-CLI program, and AstraZeneca holds an option to acquire the compounds subject to a full asset transfer agreement under which Orexo would be entitled to development milestones and royalties

The design of the trial later will be adapted, enabling it to separate into three separate personalized arms to test AZD0424 in different combinations alongside standard or other experimental treatments in specific patient populations...In other news, Boehringer Ingelheim said it enrolled the first patients in its Phase III interferon-free (IFN-free) program, HCVerso, testing its IFN-free polymodal regimen combining faldaprevir (BI 201335), a next-wave once-daily protease inhibitor, and BI 207127

Afatinib is under review for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer with an epidermal growth factor receptor mutation as detected by an FDA-approved test

Public biopharmaceutical companies, which had a great year, by and large were not able to fully leverage their increased stock valuations, successful clinical results and product approvals into follow-on and other financings...The company paid $350 million in cash, with the remainder made up of milestones: $195 million related to the development and regulatory approval of Bruton's tyrosine kinase (Btk) inhibitor AVL-292, and up to $380 million in potential payments contingent upon the development

Public biopharmaceutical companies, which had a great year, by and large were not able to fully leverage their increased stock valuations, successful clinical results and product approvals into follow-on and other financings...Signs are pointing to plenty of room in the market for the "big three," as well as many other obesity candidates making progress through pipelines...Editor's note: This article is from BioWorld Insight, the in-depth analytical companion to BioWorld Today.

Pursuant to the transaction, Coronado leased a manufacturing facility in Woburn, Mass...Ovamed agreed to assist in establishing the facility and to provide clinical supplies of the product until it's up and running...The company said it is now free to commercialize or enter into commercialization agreements for its oral BDP suite of products with other parties without limitation

The amount is in addition to approximately $500 million remaining under the previously announced $10 billion share repurchase program...Genzyme plans to request a re-examination of the CHMP Opinion...Raxibacumab also is approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate