Market News

I Holland to host a solutions-led seminar focusing on resolving tablet compression issues.

This legal form of company strengthens its position as a full-service CDMO and ensures its place as an industry leader.

CDMO, Micro-Sphere partners with German machine manufacturer Harro Höfliger for the latest step in its 21 million CHF (€19 million) investment into its facility in Switzerland.

Initial base award secures additional Imvamune bulk contract of USD 100 million.

New production line for the aseptic filling of biotech medicines under isolator.

The 30-million-euro investment will accommodate the growing needs of customers.

Use of PnuVax’s unique patented conjugation platform technology to produce the vaccine is expected to speed up biomanufacturing and increase yield for a greatly reduced per-dose cost.

Partnership will provide SGS clients with a unique additional analytical service that uses cutting-edge technology to verify product authenticity, process authenticity and product/process infringement.

CDMO partners with Pall Life Sciences to deliver an end-to-end single-use platform solution from upstream to downstream.

New center of excellence to support further development of collaborative, long-term partnerships with leading pharmaceutical companies.

CPHI onsite survey highlights emerging trends in 2017 for South Korean pharma.

The importance of ensuring a facility has the right capabilities when selecting a CMO to handle high potency ingredients.

Largest ever CPHI Pharma Awards receives 200+ entries, with judges evaluating over 250,000 words.

CDMO on target to become a one-source contract partner for early-phase development.

Project will use the company's Alphamer technology, which is based on 'programmable immunity' in which chemically synthesized molecules redirect naturally occurring antibodies to selected pathogens to fight the infection.

Two free webinars - 'Lyophilizer Sublimation and Heat Transfer Modelling' and 'The Freezing Stage in Freeze Drying: Fundamental Concepts 2.0' - delivered by industry experts.

Award-winning building protected by special construction against vibration and temperature fluctuations.

Whether you're a small, virtual firm or Big Pharma, Recipharm Pathway to Clinic can remove the complexity out of first in human projects.

Warning letter cites Meridian Medical Technologies' failure to thoroughly investigate multiple serious component and product failures of EpiPen products.

The time it takes to develop a solution has been gravely underestimated by a large part of the industry.

Important step in executing science and technology focused strategy.

In connection with the $60 million settlement, the company has also resolved several private whistle-blower cases related to the government's investigation.

Majority of the positions eliminated expected to come from a US voluntary early retirement program.

Major new tiotropium bromide DPI development programme accelerated through licensing of Pulmatrix technology.

The pivotal Phase III study demonstrated that treatment with Abraxane in combination with gemcitabine can offer patients a median overall survival improvement of 1.8 months.

Rigontec’s immuno-oncology approach of engaging the innate immune system to safely eliminate cancer cells complements Merck's strategy and current pipeline.

Vasant Narasimhan appointed CEO, effective 1February 2018.

Company consolidates its consultancy portfolio into a single, comprehensive offering.

Lofexidine is an investigational drug under development to mitigate symptoms associated with opioid withdrawal.

Company's additional 4327-sq ft floor at Clintec’s Glasgow-based headquarters forms a fully dedicated centre of excellence for clinical research and quality assurance capabilities.

Company says it is determined to work collaboratively to find a solution.

Distribution agreement covers countries in the EEA and Switzerland.

The Chinese biopharmaceutical company acquires the Canadian biomanufacturing business of Therapure.

Step towards strategic alignment of R&D resources to Healthcare priorities.

Only approved antibody-drug conjugate for newly diagnosed and relapsed or refractory CD33-positive AML.

StemFit Basic02 offers superior and stable growth performance, high colony forming efficiency and robust scalable cell expansion.

Patheon's CDMO capabilities coupled with Thermo's clinical trials services and bioproduction technologies expected to make Thermo and "even stronger partner" for its pharmaceutical and biotech customers.

MEDI1341 has the potential to achieve a better efficacy and safety profile than other alpha-synuclein antibodies.

Expansion comes as a result of increased industry demand to better understand and characterize APIs and process intermediates at the clinical stage.

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.