GW Pharmaceuticals plc, of Porton Down, UK, received commercial approval for lead cannabinoid product Sativex in Italy for moderate to severe spasticity in multiple sclerosis patients who have not responded adequately to other anti-spasticity medications...In other news, closed its initial public offering (IPO) of 3.5 million American depository shares (ADSs) at $8.90 per share...PM01183 is designed to bind covalently to the minor groove of DNA to induce a specific degradation in tumor cells of RNA

Scioderm Inc., of Durham, N.C., reported that its investigational product, SD-101, has received breakthrough therapy designation by the FDA for the treatment of patients with inherited epidermolysis bullosa (EB), a genetic disorder that causes extremely fragile skin which blisters and tears easily

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

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

Scioderm Inc., of Durham, N.C., said its investigational candidate, SD-101 , received breakthrough therapy designation by the FDA for the treatment of patients with inherited epidermolysis bullosa (EB

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

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 filing for the treatment of patients with the genotype 4 virus is based on phase II data and an ongoing phase III study

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

Pfizer Inc., of New York, said its palbociclib (PD-0332991), an oral and selective inhibitor of cyclin-dependent kinases 4 and 6, received breakthrough therapy designation by the FDA for the potential treatment of patients with breast cancer

Onyx Pharmaceuticals Inc., of South San Francisco, and Bayer HealthCare, of Wayne, N.J., part of Bayer AG, said Stivarga (regorafenib) gained approval in Japan for the treatment of patients with metastatic colorectal cancer

Celgene International Sarl, of Boudry, Switzerland,, a subsidiary of Celgene Corp., said that Revlimid (lenalidomide) has been granted full approval, which includes an Import Drug License, by the China State Food and Drug Administration for use in combination with dexamethasone as a treatment for patients with relapsed or refractory multiple myeloma who have received at least one prior therapy

Celgene International Sarl, of Boudry, Switzerland,, a subsidiary of Celgene Corp., said that Revlimid (lenalidomide) has been granted full approval, which includes an Import Drug License, by the China State Food and Drug Administration for use in combination with dexamethasone as a treatment for patients with relapsed or refractory multiple myeloma who have received at least one prior therapy

Genentech Inc., of South San Francisco, part of the Roche Group, said the FDA approved Avastin (bevacizumab) for use in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed on a first-line Avastin-containing regimen

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

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

BDP is a topically active corticosteroid that has a local effect on inflamed tissue and has been marketed worldwide since the early 1970s as the active pharmaceutical ingredient in a nasal spray and in a metered-dose inhaler for the treatment of patients with allergic rhinitis and asthma

Genzyme Corp., of Cambridge Mass., a unit of Sanofi SA, and Isis Pharmaceuticals Inc., of Carlsbad, Calif., said the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a negative opinion for its marketing authorization application for Kynamro (mipomersen) for the treatment of patients with homozygous familial hypercholesterolemia

Eisai Inc., of Woodcliff Lake, N.J., said Fycompa (perampanel) for partial epilepsy, was approved for use in Scotland after a decision by the Scottish Medicines Consortium that cleared the compound as a second-line adjunctive treatment in patients with refractory partial-onset epilepsy