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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…
Precision Medicine Group, Inc., announced it is acquiring ETHOS Health Communications, a Pennsylvania-based agency specializing in the interpretation and communication of innovative medical science. The acquisition of ETHOS, which informs physicians, providers and other stakeholders through medical affairs- and marketing-based scientific content, allows Precision to offer its clients a significantly expanded cadre of doctoral-level science and medical communications specialists. During its 15-year operating history, ETHOS has established itself as an authority in understanding and translating the science of medicine into high-level strategy and tactical execution. With a track record of long-tenured relationships with major biopharmaceutical companies and leading biotechnology firms, ETHO…
Hikma Pharmaceuticals PLC (Hikma, Group) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1 Moody’s / BB+ S&P, both stable) announces that it has signed a licensing and distribution agreement with Omega Pharma Trading NV, an affiliate of Perrigo Company plc (Perrigo), one of the largest providers of over-the-counter healthcare solutions in Europe.   Under the terms of the agreement, Hikma has the exclusive right to license and distribute more than 30 consumer healthcare products, including Davitamon, Prevalin, XLS Medical, Dermalex and Paranix, in all its MENA markets, with the exception of current agreements in place. Hikma aims to work with Perrigo’s existing partners in the MENA region to broaden sales and marketing coverage. In addition, Hikma has the right of first…
Catalent, Inc., the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced that it has agreed to acquire Juniper Pharmaceuticals, Inc. (NASDAQ: JNPR), including its Nottingham, U.K.-based Juniper Pharma Services division. When combined with Catalent’s existing industry-leading drug development and manufacturing capabilities in the U.S. and Europe, the acquisition of Juniper will expand and strengthen Catalent’s offerings in formulation development, bioavailability solutions and clinical-scale oral dose manufacturing, and will complement its integrated global clinical and commercial supply network. “Juniper’s proven solutions and capabilities will further support Catalent’s strategic goal to be…
Mesoblast Limited (Nasdaq: MESO; ASX: MSB) today announced a US$50 million financing from NovaQuest Capital Management, L.L.C. (NovaQuest) for the continued development and commercialization of its allogeneic product candidate remestemcel-L (MSC-100-IV) for children with steroid refractory acute Graft versus Host Disease (aGVHD). NovaQuest was formed in 2000 as a strategic investment unit within Quintiles (now IQVIA), the world’s largest clinical research organization, and became an independent firm in 2010.  Mesoblast’s open-label Phase 3 trial enrolled 55 children with steroid-refractory aGVHD (aged between two months and 17 years) in 32 sites across the United States, with 89% of patients suffering from the most severe form, grade C/D aGVHD. The trial was performed under…
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, and Roper Technologies, Inc. (NYSE: ROP), a leading diversified technology company, today announced that they have entered into a definitive agreement under which Thermo Fisher will acquire Gatan, Inc., a wholly owned subsidiary of Roper, for approximately $925 million in cash. Gatan is a leading manufacturer of instrumentation and software used to enhance and extend the operation and performance of electron microscopes. Gatan's technologies are used in materials science, electronics and life sciences to enable electron microscopy workflows – from specimen preparation and manipulation to imaging and analysis. These solutions, which are platform agnostic, include filter systems, cameras and proprietary software…
Sanofi presented non-inferiority results of the first ever head-to-head clinical study comparing its long-acting insulin Toujeo® (Gla-300) to insulin degludec. Results of the study, called BRIGHT, were presented today at the American Diabetes Association (ADA) 78th Scientific Sessions in Orlando, Florida, U.S.[i]   In the study, involving nearly 1,000 patients with type 2 diabetes, Gla-300 met its primary endpoint of non inferior reduction in HbA1 levels versus insulin degludec (at a non-inferiority margin of 0.3% and difference between treatments: -0.05% [95% CI −0.15 to 0.05%]). Gla-300 also demonstrated a lower rate of ‘anytime (24h) hypoglycemia’ in the first 12 weeks, the sensitive period in which patients and healthcare professionals work to determine the most appropriate indi…
Juniper Pharma Services (JPS), a Contract Development and Manufacturing Organisation (CDMO) specialising in the development of challenging small molecules, is continuing its strategic investment in oral solid dose manufacturing with a $1.7m purchase of three additional pieces of processing equipment. This investment enhances JPS’ commitment to rapidly transform promising molecules into successful products for unmet medical needs, and will ultimately lead to vital medicines reaching patients quicker.   The company has invested in three new pieces of top-specification solid dosage processing equipment: Gerteis MINI-PACTOR roller compactor, KG Pharma RoTab Bilayer tablet press and an O’Hara Labcoat Film Coater. Following the successful implementation and high client demand of the origi…
Synteract, an innovative contract research organization (CRO) providing full, phase I-IV services enabling drug development companies to bring new medicines to market, has signed a memo of understanding to partner with the International Children’s Advisory Network (iCAN). A worldwide consortium of children’s advisory groups, iCAN is dedicated to giving children and families a voice in health, medicine, research, and innovation by increasing education about the importance of children’s involvement. Synteract is a sponsor at the 2018 iCAN Research Summit in Edinburgh, Scotland, UK, July 8-13, 2018 and will hold two interactive plenary seminar sessions at the event.   With chapters across the U.S. and worldwide, iCAN partners with local children’s hospitals and addresses the…