Market News

Kymriah approvaed for children and young adults with B-cell ALL that is refractory or has relapsed at least twice.

First carbapenem-based combination product – combination of meropenem with a new class of beta-lactamase inhibitor.

Volume expected to remain somewhat constrained into the first quarter of fiscal 2018.

FDA cites two manufacturing concerns.

Collaboration to focus on a disease target in Parkinson's disease with Berg's Interrogative Biology technology.

An innovative quadrivalent influenza vaccine will complement Sanofi Pasteur vaccine portfolio.

Biogen becomes the first company with approved biosimilars for the three most prescribed anti-TNF biologic treatments in Europe.

Complaint alleges Teva failed to disclose the poor performance of its US generics business and the subsequent goodwill impairment charge stemming from the company’s purchase of Actavis Generics.

Cyltezo approved for the treatment of multiple chronic inflammatory diseases.

Appointments come as global leader in contract topical and transdermal pharmaceutical development benefits from increased revenues.

Mylan granted an exclusive license by Otsuka to prioritize access to Deltyba in South Africa and India.

Establishes Charles River as a premier source for CNS contract research services.

Collaboration grants Janssen the exclusive rights to Bavarian Nordic’s MVA-BN technology for two additional programs, targeting vaccines against hepatitis B virus and the human immunodeficiency virus.

Partnership to target multiple serious diseases using real world data studies.

Investment is in response to increased market for spray drying and capsule filling for dry powder inhalers.

Comapny has created a novel formulation to produce a product prototype containing 300 mg of Isoniazid, that is both rapidly dissolving and mucoadhesive.

Investment will fund a new office in Boston, US, an extension of its UK facility at the Oxford Science Park, and R&D capabilities to increase its intellectual property portfolio.

Models will be used in AstraZeneca's oncology R&D programs in breast and lung cancer.

Esomeprazole Strontium DR capsules 49.3 mg is an FDA-approved, proprietary, prescription proton pump inhibitor, indicated for adults for the treatment of gastroesophageal reflux disease and other gastrointestinal conditions.

Mylan will reclassify EpiPen Auto-Injector for purposes of the Medicaid Drug Rebate Program and pay the rebate applicable to innovator products effective as of 1 April 2017.

Orion's workflow tools will help Pfizer's efforts to deliver potential breakthrough therapies for patients.

Hikma granted the exclusive rights to manufacture and commercialise three of Takeda’s leading primary care product families.

Employees and capabilities will be integrated into Evotec's global drug discovery group to maximise commercial synergies.

Agreement convers the clinical application of Vectura's proprietary smart nebuliser technology to deliver Dynavax's investigational immunotherapeutic agent to lung cancer patients.

Novo Nordisk will have an option to license the FGF1 program upon achievement of certain research milestones.

Assay-ready kits will incorporate fully-validated, industry-leading recombinant antibody technology for high throughput research.

The Asian pharma event surpasses 55,000 visits with more than 10,000 overseas visits.

Major pharma manufacturer delivers critical drugs to a leading children's hospital.

Co-exclusive global licence covers manufacture and integration of CEGX TrueMethyl technology for oxidative bisulfite sequencing with Targeted Methylation and NuGEN Ovation Methyl-Seq systems.

Subsidiary to develop novel AAV gene therapy treatments for complement-mediated.

The two patents represent the next generation of SM-88, joining tyrosine and melanin into a potentially more potent combination.

Vyxeos represents the first new chemotherapy advance in more than 40 years for these adults with AML.

Company is first to offer innovative, reduced-dose HIV treatment in India.

CDSCO certification has improved international repute of India, but domestic companies call for urgent Government support to invest in API facilities.

Transaction is expected to close during Q4 2017, before which a new trade name will be selected for the Business.

Juniper Pharma Services now has CrystecPharma’s supercritical fluid technology platform on-site.

Company also becomes the first solution provider to achieve 100 pharmaceutical and contract manufacturers live and ready for serialization.

Small nimble biotechs to introduce a ‘golden age’ of next generation therapies such as CAR-T, combination therapies, innate immune system approaches, and newer check-point inhibitors.

Company alleges infringement of two patents.

Investment will increase the company's flexibility in meeting both existing and future customer demands.

Project also includes reconfigure the existing small-scale manufacturing area providing a single high-containment building to support early-stage development and manufacturing.

The company's NanoTherm therapy makes it possible to combat the tumour from within, while sparing surrounding healthy tissue.

14 new injection-molding machines and significant increase in efficiency and energy savings.

Contract dispute relates to an agreement entered into among Endo International, Penwest Pharmaceuticals and Impax.

SP Scientifc's ControLyo Central is a suite of online resources to help freeze dried parenterals manufacturers.

Federal judge enters consent decree against outsourcing facility Isomeric Pharmacy Solutions.

FDA approval is supported by an overall 98% cure rate in patients who received the recommended duration of treatment .

J+D Labs’ extensive experience manufacturing a wide-range of softgels, specialized tablets, capsules, and powder formulations complements Captek’s offerings.

Life-extending pancreatic cancer medicine to be made available immediately on the NHS.

Bolt-on acquisition adds value to other areas of Lonza’ business, including Health & Nutrition ingredients and excipients.

Romaco will additionally show Innojet process technology and Kilian services at POWTECH.

Gains full rights to IFM’s preclinical STING and NLRP3 agonist programs focused on enhancing the innate immune response for treating cancer.

EP Vantage releases half-year reviews of pharma & biotech and medtech performance.

The launch represents a major step towards therapeutic use of CRISPR.

Baxter plans to invest in further increasing Claris Injectables’ capacity and capabilities, including adding new aseptic manufacturing and lyophilization.

Company can now offer solutions for serialized receiving, picking, shipping, returns, deactivation, aggregation, de-aggregation, label printing and tag management of pharmaceutical products.

Guide aims to help the operator understand the complex protocols and heavily regulated procedures associated with pharmaceutical cleanrooms.

The merger enables STA to advance NCEs from pre-clinical stage to New Drug Application and to market faster and more efficiently for pharma and biotech customers.

Pivotal Phase III trials planned for 2017 will evaluate Rubraca + Opdivo, Rubraca as monotherapy, and Opdivo as monotherapy in first line maintenance treatment for advanced ovarian and advanced triple-negative breast cancers.

Dalton Pharma Services is preparing glass vials in three varying dose formulations for the clinical kits needed to support the Phase I safety trial for AB569 at the CVAMC later this year.

Collaboration aims to maximize the potential of PARP and MEK inhibitors in combination with PD-L1/PD-1 medicines, based on growing scientific evidence that these combinations offer new potential for the treatment of a range of tumor types.

The new facilities enable to company to further grow and flourish.

The mPath bioreactor control system is the first to be developed and delivered by a technology supplier specifically for their product line, allowing full access to bioreactor capabilities that current commercial solutions cannot provide.

The CPHI predictions foresaw advancement in QbD, continuous processing, and a dramatic rise in FDA warning letters.

Deal builds on ongoing collaboration to develop vaccines for Human Papillomavirus (HPV) and Ebola.

Dermatology unit is rebranded Ortho Dermatologics.

Company launches Ibex innovation in biological development and manufacturing.

Thermo's Samco Clicktainer vials provide secure and reliable sample collection and transport.

First generic prequalification for sofosbuvir tablets.

New approval for treatment of active psoriatic arthritis (PsA).

Vertex now has worldwide development and commercialization rights to CTP-656 and other assets related to the treatment of cystic fibrosis.

AI thought to have massive potential to reduce the cost associated with the discovery of new drugs.

40% of industry professionals admit they are not clear about the global requirements for serialization.

STA will provide supplies of certain starting and intermediate materials for the recently launched Zejula.

The biosimilar's list price will represent a 35% discount to the current list price of Remicade.

NKTR-358 has the potential to treat a number of autoimmune and other chronic inflammatory conditions.

The approval marks the first subcutaneous self-injection treatment option for patients with systemic lupus erythematosus.

Expansion will triple capacity, add nearly 300 new jobs.

Collaborations result in development of Corning Valor Glass.

GMP Manufacturing line industrialised according to a unique process invented by LIDDS, involving the installation of novel equipment that is new to the pharmaceutical industry.

Goal of the collaboration is to identify therapies and diseases for which there is a high need for pediatric-friendly formulations.

IHAT, a novel synthetic material, is a commercially viable alternative to ferrous salts for iron supplementation.

With support from the CRO, TopiVert has been able to accelerate scale-up and produce GMP batches, which are now being used in clinical trials.

Company announces investments, the sale of several products and a proposal to close a UK manufacturing site.

Overseas buyers at CPHI Korea double in the past 2 years.

Investment follows demand for the company's AseptiSafe and PharmaSafe product ranges, which transfer APIs in small- and large-scale pharmaceutical manufacturing environments.

Nerlynx is the first extended adjuvant therapy for patients with HER2-positive breast cancer.

Shire obtains worldwide license to pursue development and commercialization of a novel, potentially differentiated, pre-clinical bi-specific antibody candidate for Hemophilia A.

Company has experienced double digit growth across its automation, MES and managed services offering.

The service offers quick and efficient path from late-stage discovery to Phase I clinical trials.

Company expects to launch by the end of the year.

Company expects to supply up to 40 million doses across both vaccines for the US market in the 2017-18 season.

The system's new, variable transport system avoids bottlesnecks or delays in workflow.

Company to invest €90 million and cut 200 jobs.

Patients in Scotland will now join those in England and Wales and be able to benefit from this potentially life-extending immunotherapy on the NHS.

Acquisition adds recombinant-based influenza vaccine to Sanofi Pasteur's portfolio.

Cobalt's portfolio of solutions accelerates entry into high-growth Raman spectroscopy market and expands Agilent’s value proposition for pharmaceutical and biopharma customers.

The 2017 awards include eight new categories - celebrating outstanding achievements in the pharma industry.

Selexipag is an innovative, oral treatment that specifically targets the prostacyclin pathway.

NEXUS 17 attendees claim the greatest serialization challenge thus far has been line vendors’ inability to deliver a solution on time and within scope.

Actavis's products directly infringe Lilly's vitamin regimen patents in the UK, France, Italy and Spain.

The new 5-axis machine will speed up the production and delivery of larger diameter valves up to 350 mm.

IH-TMS Tool Management System and the company's latest tool coating solutions interest exhibition visitors.

Acquisition create leading integrated solutions provider to the global pharma and consumer healthcare industries.

Company has immediately initiated commercialization activities.

Label update includes 52 week data from CLEAR study demonstrating long-term superiority of Cosentyx versus Stelara in psoriasis.

Pharma clients now have direct and immediate access to a fully compliant safety database without needing to invest in their own system or use an interim solution to ensure compliance.

Brilliance tubes provide a user-friendly and attractive all-in-one solution.

First shipment of BIOCAD’s Acellbia to India is scheduled for September 2017.

Tildrakizumab is an investigational IL-23p19 inhibitor being evaluated for the treatment of moderate to severe plaque psoriasis.

Idifarma, a Spanish CDMO, has expanded its GMP manufacturing offering with the installation of new automatic capsule filling capabilities at its EU-GMP approved plant in Pamplona, Spain.

In clinical studies, baricitinib has demonstrated significant improvement in the signs and symptoms of RA compared to standard-of-care therapies.

Three new TurboVap evaporation systems increase laboratory reliability.

Developed to support assay development and validation for detection of anti-drug antibodies.

Pre-clinical collaboration focused on up to 10 targets nominated by GSK.

Investments in commercial and development spray drying, and flexible manufacturing solutions.

Strengthens leadership in rare blood disorders with first-in-class candidate to treat cold agglutinin disease, a chronic autoimmune hemolytic anemia with no approved therapies.

The Chaim Sheba Medical Center now offers the hydrogel spacer to reduce side-effects during prostate cancer radiation therapy.

Company's modification makes the SPU 2000 a more cost effective laboratory tool.

New world-scale ibuprofen production plant in Ludwigshafen; additional capacity expansion of ibuprofen plant in Bishop, Texas.