Clinical research - Today Stories

Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ) (TSX: ARZ) ("Aralez" or the "Company") announced today that it intends to enter into purchase agreements with two separate stalking-horse purchasers to sell its main operating businesses:  an agreement to sell its VIMOVO® royalties and Canadian operations to Nuvo Pharmaceuticals Inc. ("Nuvo") in a transaction valued at U.S.$110 million and an agreement to sell its TOPROL-XL® Franchise to its secured lender, certain funds managed by Deerfield Management Company, L.P., in a transaction valued at U.S.$140 million. The Company is also engaged in ongoing efforts to sell the assets not being sold in either of the proposed transactions and intends to wind down its operations following the consummation of the sales. The letters of intent signed…

NuVasive, Inc. (NASDAQ: NUVA) and Siemens Healthineers today announced a strategic partnership focused on technology development, marketing and commercial activities to advance clinical outcomes in minimally invasive spine surgery. NuVasive is an innovation leader in spine health technology, focused on transforming spine surgery with minimally disruptive, predictable and clinically reproducible procedurally-integrated solutions, while Siemens Healthineers offers surgeons a broad portfolio of imaging systems including 3D imaging for complex spine cases. In their Spine Precision Partnership™, the companies will join forces in advancing their proprietary technologies with the objective of creating solutions which improve operating room (OR) workflow efficiency and provide increased precision…

XcellBio, a proprietary provider of primary cell control technologies for immunotherapeutic solutions today announced a collaboration with Carolina BioOncology Institute (CBI) to further pre-clinical development of true personalized medicine therapies. CBI will utilize XcellBio's products to expand and profile patient derived tumor and immune cells through the use of the AVATAR™ systems in CBI's pre-clinical development and validation programs.  The novel technology and research program mimics the immune and tumor microenvironments providing fine control over both the quantity and quality of cells produced to develop the highest level cell therapies. "With our proprietary primary cell control platform, we provide deeper insight into cellular profile and responses in the various HME s…

Almirall entered into a definitive agreement to acquire an Allergan U.S. portfolio* of mature and growth brands for acne and dermatoses, including a new innovative NCE, SeysaraTM  (sarecycline) for the oral treatment of acne. The closing of this transaction is expected in Q4 2018 With this strategic and very focused transaction, Almirall significantly reinforces its position in the largest dermatology market in the world All products will be distributed through our US platform and team, which has deep knowledge of the oral acne market and the acquired portfolio. They will provide critical mass to launch KX2-391, which has the potential to become the new standard of care in actinic keratosis The acquired portfolio generated net sales of $70MM in the first half of 2018 and offers…

Oxford BioMedica plc (LSE:OXB) (“Oxford BioMedica” or “the Group”), a leading gene and cell therapy group, today announces that it has entered into a process development collaboration agreement with the UK Cystic Fibrosis Gene Therapy Consortium (GTC) and Imperial Innovations to develop a long-term therapy for patients with cystic fibrosis (CF). Concurrently with this, a separate option and license agreement has been signed between Oxford BioMedica and Boehringer Ingelheim.   The collaboration will use a novel, replication deficient lentiviral vector, in an inhaled formulation, to selectively introduce a CFTR gene into the relevant target cell. This approach has demonstrated high gene transfer efficiency, and offers the possibility of repeated administration to maintain a therapeuti…

Merck, the vibrant leading science and technology company, and InnoCore Pharmaceuticals; Groningen, Netherlands, have entered into a global cooperation agreement to provide InnoCore’s proprietary SynBiosys® biodegradable polymer platform. The drug delivery platform can be used to develop sustained release solutions for biologicals in injectable formulations.   “Until now, formulating large biological active pharmaceutical ingredients such as proteins and large peptides into long-acting sustained release formulations has been difficult, if not impossible,” said Andrew Bulpin, head of Process Solutions at the Life Science business sector of Merck. “This collaboration will bring long-acting release of protein therapeutics to market, allowing new and potentially life-changing treatments…

WebMD Health Corp., an Internet Brands company and the leader in health information services for consumers and physicians, today announced that it has acquired MediQuality, the leading digital and online provider of information for health care professionals in Benelux (Belgium, the Netherlands, and Luxembourg).    Based close to Brussels, MediQuality reaches more than 50,000 physicians and other health care professionals each month, providing medical news and information, and comprehensive coverage of major medical congresses and conferences.  In addition, an authenticated and trusted online community generates physician engagement and real-time, peer-to-peer discussions of clinical trends and issues. "MediQuality's commitment to providing Benelux physicians with quality i…

LabCorp® (NYSE: LH), a leading global life sciences company that is deeply integrated in guiding patient care, and Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced a collaboration to further advance digital pathology. Through the implementation of the Philips IntelliSite Pathology Solution, LabCorp will incorporate digitized workflows within its anatomic pathology services, which are an integral component of its comprehensive clinical laboratory and end-to-end drug development services. Philips IntelliSite Pathology Solution is the first, and currently the only, digital pathology solution marketed for primary diagnostic use in the US. It aids pathologists in the review and interpretation of digital images of surgical pathology slides that are pre…

Merck, the vibrant leading science and technology company, and InnoCore Pharmaceuticals; Groningen, Netherlands, have entered into a global cooperation agreement to provide InnoCore’s proprietary SynBiosys® biodegradable polymer platform. The drug delivery platform can be used to develop sustained release solutions for biologicals in injectable formulations. “Until now, formulating large biological active pharmaceutical ingredients such as proteins and large peptides into long acting sustained release formulations has been difficult, if not impossible,” said Andrew Bulpin, head of Process Solutions at the Life Science business sector of Merck. “This collaboration will bring long-acting release of protein therapeutics to market, allowing new and potentially life-changing treatments. It wil…

Q BioMed Inc. (OTCQB: QBIO), a commercial stage biotechnology acceleration development company is pleased to announce that it is extending its option agreement with Washington University in St. Louis. Under the agreement granting the exclusive right to license the technology, Q BioMed will continue to evaluate the feasibility and usability of GDF15, a novel biomarker for monitoring glaucoma, as a companion diagnostic to the MAN-01 small molecule currently being optimized for the topical treatment of glaucoma. The extension allows for more extensive evaluation to be conducted on the feasibility and usability of GDF15 as a novel biomarker for glaucoma and companion diagnostic to, Q BioMed’s exclusively licensed technology, MAN-01. Dr. Arsham Sheybani, Assistant Professor of Ophthalmology an…

Sutro Biopharma, Inc.,  has signed a collaboration and licensing agreement with Merck, known as MSD outside the United States and Canada, to discover and develop novel immune-modulating therapies for cancer and autoimmune disorders. The research and development activities will leverage Sutro's proprietary cell-free protein synthesis and site-specific conjugation platforms, which facilitate precision design and rapid empirical optimization of protein conjugates, to discover and develop best-in-class immune-modulating cytokine derivatives for both oncology and autoimmune indications. Under the agreement, Sutro will be primarily responsible for preclinical research and Merck will gain exclusive worldwide rights to therapeutic candidates derived from the collaboration. Sutro will recei…

PureTech Health plc (LSE: PRTC) ("PureTech Health"), a clinical-stage biopharmaceutical company developing novel medicines focused on the Brain-Immune-Gut (BIG) Axis, today announced that it has entered into a multiyear collaboration with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc., to advance PureTech’s milk-derived exosome platform technology for the oral administration of Roche’s antisense oligonucleotide platform. Under the terms of the agreement, PureTech Health will receive up to $36 million, including upfront payments, research support, and early preclinical milestones. PureTech Health will be eligible to potentially receive development milestone payments of over $1 billion and additional sales milestones and royalties for an undisclosed number of products.   PureTech…

TrakCel, the software developer for cell and gene therapy supply chain tracking and orchestration systems, and Mustang Bio, Inc. (“Mustang”) (NASDAQ: MBIO), a Fortress Biotech (NASDAQ: FBIO) Company focused on the development of novel immunotherapies based on proprietary chimeric antigen receptor engineered T cell (CAR T) technology, today announce that they have partnered to build a custom-configured cellular supply chain tracking and orchestration platform. The platform will be used in the clinical development and commercialization of Mustang’s CAR T therapies. Financial details of the partnership have not been disclosed.    The software platform will enable Mustang’s clinical and logistics teams to have complete visibility across all protocols down to the individual patient…

Today, Theramex and Endoceutics announced they have entered into a definitive agreement granting Theramex the license to commercialise Intrarosa® (Prasterone) across countries in Europe, Australia, Russia as well as select countries within the Commonwealth of Independent States (CIS). Intrarosa is a unique non-estrogen prescription therapy approved for the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women experiencing moderate to severe symptoms. VVA can lead to dryness, irritation and dyspareunia (or pain during sexual activity). Anish Mehta, Chief Executive Officer at Theramex said "Intrarosa is a novel medicine that offers an effective treatment for a very common condition in postmenopausal women.  We are pleased to be able to continue the ground-breaking work…

EUSA Pharma (EUSA), a biopharmaceutical company focused on oncology and rare disease, announced today that it has entered into a definitive agreement with Janssen Sciences Ireland UC, a subsidiary of Janssen R&D Ireland (Janssen) to acquire the global rights to SYLVANT® (siltuximab) for $115 million in cash. The transaction is subject to review under the United States Hart–Scott–Rodino Antitrust Improvements Act of 1976, as amended, and the parties expect to close following completion of this regulatory review period and the mutual satisfaction of other remaining closing conditions.   SYLVANT® is approved in more than 40 countries worldwide, including the United States, the European Union, the Republic of Korea and Canada, for the treatment of idiopathic multicentric Castleman’s…

AMPAC Fine Chemicals ("AFC"), a leading US-based Contract Development and Manufacturing Organization ("CDMO"), today announced its sale to SK Holdings ("SK"), an investment holding company of SK Group (South Korea). This acquisition is the largest M&A transaction announced in the Korean pharmaceutical industry. Since February 2014, AFC has been owned by H.I.G. Capital ("H.I.G."), a global private equity firm. Under H.I.G.'s ownership, AFC expanded the manufacturing footprint at Rancho Cordova, CA facility, started AMPAC Analytical, acquired a state-of-the art plant in Petersburg, VA, substantially enhanced its product pipeline, and delivered industry-leading growth every year since acquisition.  SK is purchasing AFC due to its unique capabilities, world class facilities, excelle…

Akcea Therapeutics, Inc. (NASDAQ: AKCA), an affiliate of Ionis Pharmaceuticals, Inc., and Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), announced today that TegsediTM (inotersen) has received marketing authorization approval from the European Commission (EC) for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR). This follows the positive opinion recommending approval provided by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).[i] Click here to view the EC’s decision. “With the EC’s decision, inotersen is now the world’s first and only RNA-targeted therapeutic approved for patients with hATTR amyloidosis. With subcutaneous delivery, inotersen puts treatment in the patients’ h…

Bruker Corporation today announced that it has acquired JPK Instruments AG (JPK), located in Berlin, Germany. In 2017, JPK Instruments had revenue of approximately 10 million Euro. JPK provides microscopy instrumentation for biomolecular and cellular imaging, as well as force measurements on single molecules, cells and tissues. JPK adds in-depth expertise in live-cell imaging, cellular mechanics, adhesion, and molecular force measurements, optical trapping, and biological stimulus-response characterization to Bruker. Financial details of the transaction were not disclosed. Over the past five years, Bruker has developed a life science microscopy business that specializes in advanced technologies for neuroscience, live-cell imaging, and molecular imaging, which will be further augmented by…

Synteract, an innovative contract research organization (CRO) providing full-service Phase I-IV clinical trials, has acquired Cu-Tech, LLC, the leading dermatology specialist CRO. In coming together with Cu-Tech, Synteract has created a dedicated center of dermatology development, making the combined company the leading midsized global CRO for dermatology clinical trials. Cu-Tech is an industry-renowned dermatology CRO with more than two decades of experience, having managed 130+ dermatology trials. The New Jersey-based CRO is known for its strong relationships with its clients and investigative sites, as well as for its expertise in working across a variety of dermatological indications. Steve Powell, CEO of Synteract, says, “The acquisition of Cu-Tech represents the next step…

Sofinnova Partners, a leading venture capital firm specialized in Life Sciences, today announced that Otsuka Holdings is acquiring its portfolio company ReCor Medical, a medical device company specialized in the treatment of hypertension. The terms of the acquisition are being withheld due to non-disclosure obligations.   ReCor Medical was created in 2009 by Sofinnova Partners, Mano Iyer – who was then entrepreneur-in-residence at Sofinnova Partners and now Chief Operating Officer of ReCor – and Professor Jacques Seguin, MD, who became a large private investor in ReCor. Prof. Seguin was previously founder and CEO of CoreValve, a past Sofinnova portfolio company and a leader in the transcatheter valve replacement space, which was sold to Medtronic. Sofinnova Partners was the sole ven…