All News
All news
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News Clinerion introduces new services for market access
Disease prevalence can be monitored with a precision never before possible. -
News Zymeworks opens state-of-the-art lab facility
Provides the company with increased control over discovery research, antibody generation, medicinal chemistry and bioconjugation for generating antibody drug conjugates. -
News Intrexon to acquire GenVec to expand industry-leading gene delivery platform
GenVec's AdenoVerse to be integrated into Intrexon's proprietary synthetic biology platform. -
News SGS increases extractables and leachables identification capabilities at its Fairfield, NJ laboratory
Investments include an LC-MS/MS, and GC-MS with head-space capability, for improved and rapid identification of trace unknown extractable compounds. -
News Vetter starts operations in its center for visual inspection and logistics
Site enlargement enables increased capacity for state-of-the-art quality control and storage. -
News FDA approves IND for Vectura's VR647
VR647 is a drug/device combination, using the AKITA JET smart nebuliser, for the delivery of nebulised budesonide. -
News Enteris and Sanofi to develop oral therapeutic for type 2 diabetes
Feasibility study to examine three different oral formulations engineered with Enteris’ Peptelligence platform. -
News Enamine expands collaboration with Europe’s largest biopharmaceutical company
Extends multi-year agreement in drug discovery with focus on cardiovascular and central nervous system disorders, immunology, infectious diseases and oncology. -
News Irvine Scientific introduces PRIME-XV T cell CDM for immunotherapy applications
The first chemically-defined, animal component-free, cell culture medium for T cells. -
News Molecule shows ability to thwart pathogens’ genetic resistance to antibiotic
The molecule, which is a PPMO, will likely be ready for testing in humans in about 3 years. -
News Endo agreement to resolve FTE investigation and litigation
No admission of wrongdoing, No monetary payment by Endo. -
News BMS, Ono Pharma and Merck resolve PD-1 antibody patent litigation
Merck to pay BMS and Ono royalties on global sales of Keytruda through 2026, and lump-sum payment of $625 million. -
News Concert Pharmaceuticals receives FDA orphan drug designation for CTP-656 for the treatment of CF
Topline results from the Phase II trial are expected by year-end 2017. -
News EMA validates Gilead’s MAA for investigational chronic Hep C therapy
Sofosbuvir/Velpatasvir/Voxilaprevir cranted an accelerated assessment by the EMA. -
News Mylan acquires Cold-EEZE brand to further expand OTC business
Cold-EEZE will become Mylan's largest US OTC brand franchise. -
News FDA approves Allergan's Rhofade cream, 1% for persistent facial erythema
Once-daily treatment reduces persistent facial erythema associated with rosacea through 12 hours. -
News Opdivo demonstrated efficacy and improved survival in patients with previously treated advanced gastric cancer
Opdivo demonstrated a 37% reduction in the risk of death compared to placebo. -
News I Holland hosts a live webinar to help customers maximise their tablet tooling life
Getting the most out of punches and dies with a simple and powerful tooling management system. -
News Takeda and Ovid Therapeutics shake on innovative collaboration for TAK-935 in rare pediatric epilepsies
Collaboration between pharma and biotech underscores potential for new approaches to partnering. -
News Sartorius Stedim Biotech supports mainstream adoption of Quality by Design
Unique technology portfolio enables design space characterization, effective translation to the large-scale and enhanced process analytics. -
News Lilly to acquire CoLucid for $960 million
Deal will enhance Lilly's existing pain management portfolio for migraine and adds potential near-term launch to its late-stage pipeline. -
News Hikma receives FDA approval for generic equivalent to Xyrem
Company's subsidiary currently involved in patent litigation concerning this product. -
News CPHI SEA adds six new features
The South East Asia exhibition now includes Investment Forum, Roadshows and Business Matchmaking. -
News Merck opens production facility exclusively for meglumine
Regulatory compliant, FDA-audited facility based in Mollet des Vallès, Spain. -
News Biogen agrees to pay Forward Pharma $1.25 billion
The settlement and license agreement will strengthen Biogen's IP for leading oral therapy for multiple sclerosis. -
News Selonterra publishes novel proprietary mechanism for APOE4 in Alzheimer’s disease
Therapies targeted at this novel mechanism have the potential for disease-modification because they will address the genetic root cause of AD. -
News Suliqua approved in the EU for the treatment of adults with type 2 diabetes
Suliqua will be delivered in two pre-filled SoloSTAR pens, providing different dosing options that may help answer individual market and patient insulin needs. -
News New natural molecule better than morphine to be tested on humans
Opiorphin represents a new class of potent and safe painkiller. -
News MicroJect Reactor technology to take centre stage in new partnership
leon nanodrugs' MJR technology offers reformulation options that address API solubility issues. -
News A-Skin secures patent for groundbreaking skin engineering therapy
WHF therapy can be directly applied on a wound to stimulate the natural human wound healing process. -
News Ipsen to acquire oncology assets from Merrimack Pharmaceuticals
Transaction includes US commercialization rights for Onivyde for metastatic pancreatic cancer in adult patients. -
News Tesaro receives CRL for rolapitant IV from FDA
No concerns raised by FDA related to the rolapitant IV efficacy or safety profile and additional clinical studies are not required. -
News Pharma in South East Asia wins through innovation, M&A, JVs and strategic partnerships to spur markets integration
Rising demand for all categories of medicines, especially generic drugs. -
News New-generation mealtime insulin approved in Europe
Novo Nordisk to launch Fiasp in first half of 2017. -
News VivaGel BV granted QIDP and Fast Track designation by FDA
Product receives designations for both the BV treatment and prevention indications. -
News Sartorius Stedim Biotech opens a new validation service laboratory at its Shanghai site
Comprehensive validation services for the Chinese market. -
News Merck Licenses four oncology R&D programs from Vertex
All programs (two promising clinical-stage programs targeting DNA damage and repair, and two novel pre-clinical programs) have first-in-class and best-in-class potential. -
News FDA grants Fast-Track Designation to RHB-104 for nontuberculous mycobacteria infections
RHB-104 is a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation. -
News US Court of Appeals rules in Lilly's favour on Alimta vitamin regimen patent
If the patent is ultimately upheld through all remaining challenges, Alimta would maintain US exclusivity until May 2022. -
News FDA accepts BLA for Mylan and Biocon's proposed biosimilar trastuzumab
If approved, MYL-1401O has potential to be the first biosimilar trastuzumab in the US. -
News Lilly and Merck expand immuno-oncology collaboration
New study to evaluate combination of Lartruvo and Keytruda. -
News Stellar Biotechnologies advances strategic plan to secure key production region
Company aims to increase production capacity to supply multiple commercial-scale therapeutic vaccines under development. -
News Piqur and Pierre Fabre announce partnership in dermato-oncology
Collaboration will give Pierre Fabre the option to enter into exclusive negotiations to license global rights for the program in selected skin cancer conditions. -
News Merck expands end-to-end biodevelopment centers
Expansionincludes the opening of two new process development centers in the US and China. -
News Pharma predictions for 2017: the good, the bad, and the Donald
Orphan drugs, CMO continuous manufacturing and developing world sales offer biggest revenue opportunities. -
News Innova Biosciences introduces the Conjugate Check&Go! Kit
Scientists can confirm, in one easy step, whether an antibody has been successfully conjugated. -
News Aurobino subsidiary to acquire Generis Farmaceutica
Generis is the most sold pharmaceutical brand in Portugal, and is the #2 generic group in Portugal. -
News Allergan obatins worldwide rights to microbiome GI development programs
Deal expands Allergan's innovative GI [ipeline with ABI-M201 and ABI-M301, preclinical compounds targeting Uucerative colitis and Crohn's disease, as well as future compounds for irritable bowel syndrome. -
News Takeda and PvP Biologics sign development agreement around novel therapeutic for celiac disease
KumaMax could provide hope celiac patients who try, but are unable to completely avoid gluten exposure in their diets, -
News Catalent to develop softgel capsules for JOT's leading orphan disease candidates
JOTROL is being developed to remedy resveratrol’s poor bioavailability and dose limiting gastrointestinal side effects. -
News Cardinal Health reaches $20 million settlement with West Virginia
Company collaborating with all participants in the pharma supply chain to tackle to the epidemic of prescription drug abuse. -
News Ariad to be acquired by Takeda for $5.2 billion
Ariad stockholders to receive $24.00 per share in cash. -
News Ascendia Pharmaceuticals awarded new patent on its ASD-002 program for acute coronary syndrome
A ready-to-use, stable and soluble, parenteral form of clopidogrel is feasible using the company's nanoemulsion platform technology. -
News Lilly to adjust organization and leadership structure
Christi Shaw hired to lead Bio-Medicines; Conterno to assume additional geographic responsibilities, including Lilly USA leadership; Zulueta to lead International business. -
News BMS and Janssen to collaborate to evaluate Opdivo in combination with Darzalex
Phase Ib/II studies to explore a novel immuno-oncology combination in hematological and solid tumours with high unmet medical need. -
News Noxxon Pharma licenses and assigns preclinical Spiegelmer programs to Aptarion
Noxxon continues transition to clinical oncology company. -
News Xigen’s innovative JNK inhibitor, Brimapitide, delivers positive Phase II results in inflammatory eye disease
The company's long-acting therapeutic peptides are designed to allow the efficient delivery of the active element to intracellular targets. -
News Lonza concludes divestment of peptides business and operations in Braine-l’Alleud, Belgium
PolyPeptide Laboratories' acquisition brings immediate access to additional large-scale capacity in synthesis, purification and isolation of peptides. -
News FDA accepts for filing sNDA for Liletta 52 mg
Application seeks to extend duration of use up to 4 years for Liletta. -
News RedHill Biopharma announces exclusive US co-promotion agreement with Concordia for GI drug Donnatal
Concordia will continue to be responsible for the manufacturing and supply of Donnatal in all territories. -
News Directorate change at Shire
Appointment of Ian Clark as Non-Executive Director. -
News SP Scientific launches new PennTech website
Website allows visitors to simply and quickly locate pertinent information. -
News Ensuring robust lyophilization scale-up
Presentation provides new data regarding the mechanism of the ControLyo Technology. -
News Sanofi Pasteur and MSD end joint vaccines business in Europe
Each company will separately pursue their own vaccine strategies in Europe. -
News Corbus Pharmaceuticals completes Phase II study of JBT-101 for the treatment of cystic fibrosis
Resunab is designed to resolve inflammation thus having the potential to provide significant clinical benefit to CF patients, importantly without immunosuppression. -
News PharmaCyte Biotech’s cannabinoid therapy may offer potential for childhood brain cancers
Reported research continues to demonstrate the anti-cancer properties of cannabinoids. -
News Pharmaserv Logistics to provide logistics services for Valneva
Pharmaserv Logistics, which specialises in pharmaceutical logistics, temperature-controlled exports and pre-wholesale solutions, has concluded a contract with vaccine manufacturer Valneva for the supply of extensive pharmaceutical logistics services. ... -
News NIPTE is partner in newly announced National Biopharmaceutical Manufacturing Institute
The participating NIPTE team will primarily focus on biopharmaceutical formulations and product development, and FDA regulatory science. -
News Bavarian Nordic initiates trial of CV301 in combination with nivolumab in patients with lung cancer
Study is exploring potential benefits of combining a cancer vaccine and PD-1 checkpoint inhibitor. -
News BioNet receives Thai FDA approval of the world's only available recombinant monovalent acellular Pertussis vaccine
BioNet's vaccine is the first recombinant monovalent Pertussis vaccine in the world to receive a MAA for booster indication in adolescents and adults. -
News Provectus Biopharmaceuticals terminates Peter Culpepper as Interim CEO and COO
Investigation reveals improper expense reimbursements. -
News Positive Phase III results of Genentech’s investigational medicine Ocrevus
Ocrevus is the first and only investigational medicine to show superior efficacy versus comparators in both relapsing and primary progressive multiple sclerosis in clinical studies. -
News FDA approves Shire's Adynovate
New FDA-approved indications for Adynovate provides more hemophilia A patients access to proven prophylaxis with a simple, twice-weekly dosing schedule. -
News FDA places clinical hold on several Phase I trials of Vadastuximab Talirine
Six patients have been identified with hepatotoxicity, including several cases of veno-occlusive disease, with four fatal events. -
News JAMA publishes Mylan and Biocon's proposed biosimilar trastuzumab Phase III data
Published study results showed an overall response rate of 69.6% for MYL-1401O compared to 64% for branded trastuzumab. -
News Pfizer completes acquisition of small molecule anti-infective business from AstraZeneca
Agreement includes the commercialization and development rights to the newly approved EU drug Zavicefta (ceftazidime-avibactam). -
News Recursion receives industry awards for drug discovery platform
Computationally intelligent drug discovery platform receives two Fierce Innovation awards for Biotech Innovation and Best New Product. -
News FDA approves first drug for spinal muscular atrophy
Spinraza improved motor function in SMA patients. -
News Vectura and Mundipharma sign global development programme
Development and licence agreement is for pMDI inhaled triple therapy (VR2076) for asthma and COPD. -
News Cardinal Health agrees to pay $44 million to the Department of Justice
Payment resolves the outstanding civil penalty portion of the company's 2012 administrative settlement with this US DEA. -
News New formulation of linaclotide may produce additional relief of abdominal pain in patients with IBS-C
Abdominal pain improved 56% with CR1 300 mcg relative to placebo in Phase IIb trial. -
News New pill available on the NHS for patients suffering with psoriatic arthritis
Oral Otezla receives positive NICE recommendation for adults with psoriatic arthritis. -
News Leadership transition for Impax Laboratories
Mr Wilkinson no longer President and CEO and a member of the Board. -
News Metformin products, including Glucophage approved for type 2 diabetes patients with moderate renal impairment in Europe
European Commission decision confirms Metformin for treatment in type 2 diabetes patients with moderate renal impairment, which will lead to extended treatment access. -
News FDA extends review of application for Ocrevus
Extension is the result of the submission of additional data regarding the commercial manufacturing process of the biologic. -
News Baxter to expand portfolio of essential generic injectable medicines with acquisition of Claris Injectables
Acquisition adds global portfolio of sterile injectables, robust pipeline, and manufacturing capabilities. -
News Licensing agreement signed for the launch of Utibron/Seebri in the US
Novartis and Sunovion Pharmaceuticals strike agreement for three COPD treatments. -
News Giovanni Caforio named chairman of BMS’s Board of Directors
Caforio will succeed Lamberto Andreotti effective 2 May 2017. -
News FDA grants accelerated approval to Rubraca for the treatment of advanced ovarian cancer
First and only PARP inhibitor in the US indicated t.o treat advanced ovarian cancer patients who have been treated with two or more chemotherapies and who have deleterious germline or somatic BRCA mutations. -
News Ionis and AstraZeneca advance first generation 2.5 LICA drug into preclinical development to treat CV disease
Ionis earns $25 million milestone payment. -
News Allergan to acquire Acelity's LifeCell Corporation for $2.9 billion
Key products include Alloderm and Stratticem tissue matrices commonly used in breast reconstruction and abdominal wall surgeries. -
News Aurinia and Lonza enter long-term manufacturing collaboration for clinical supply of voclosporin
The agreement also provides an option to have Lonza exclusively supply API for up to 20 years. -
News Novartis bolsters ophthalmology pipeline through acquisition of Encore Vision
Acquisition of Encore Vision, to add first-in-class disease modifying topical treatment for presbyopia patients to the Novartis ophthalmology pipeline in an area of high unmet medical need and high prevalence -
News Sterling and TPI strike codeine agreement
Agreement is the first step in TPI Enterprises’ plan to expand its presence in the UK market. -
News AmpliPhi Biosciences reports favorable final results from Phase I trial of AB-SA01 in CRS patients
AB-SA01 meets primary endpoints of safety and tolerability and reduces S. aureus bacterial load in all patients. -
News FDA approves removal of boxed warning regarding serious neuropsychiatric events from Chantix labeling
Labeling revisions also include updates to corresponding warning and addition of clinical data on superior efficacy of Chantix compared with bupropion or nicotine patch. -
News Sanner IDP-Process – individual packaging in six steps
Pharmapack 2017: focus on tailor-made packaging. solutions -
News Boehringer Ingelheim and Lilly welcome new recommendation for Jardiance tablets in updated ADA's 2017 Standards
Guidelines include new recommendation to consider the use of Jardiance in people with type 2 diabetes and established cardiovascular disease to reduce the risk of cardiovascular death. -
News New Repatha dose delivery option receives positive CHMP opinion
The new automated mini doser with prefilled cartridge is a hands-free device designed to provide 420 mg of Repatha in a single injection per administration. -
News Mylan launches the first generic for EpiPen Auto-Injector as an authorized generic
Authorized generic offered at more than 50% below wholesale acquisition cost of EpiPen auto-injector. -
News Merck's Idenix Pharmaceuticals awarded $2.54 billion for infringement of a hepatitis C drug patent
In its decision, the jury also concluded that Gilead “willfully” infringed upon the patent. -
News Oxford Genetics secures £1.61m grant to establish next-generation bioproduction technologies
The project aims to create a step-change in the capabilities of current bioproduction methods, meeting unmet needs in the field of viral vector production. -
News bluebird bio and apceth Biopharma establish commercial drug product manufacturing agreement
apceth Biopharma will perform clinical manufacturing, process validation activities and commercial manufacturing for LentiGlobin and Lenti-D drug product. -
News Lonza to acquire Capsugel
Acquisition will make Lonza a fully integrated solutions provider in oral delivery technologies and active ingredients to the consumer healthcare and nutrition markets. -
News Catalent Biologics to collaborate with PATH Malaria Vaccine Initiative
Catalent Biologics will employ its proprietary GPEx cell line technology and ambr workstation to develop, optimize the process for expression, and manufacture antibodies for further investigation by MVI and its partners. -
News Pfizer's acquired Xtandi fails to meet its primary endpoint in study
Phase IV study demonstrates a lack of improvement in progression-free survival in patients with chemotherapy-naïve metastatic CRPC whose prostate-specific antigen has previously progressed on Xtandi. -
News Expansion of Sartorius Stedim Cellca
Laboratory and office facility to be constructed on the site by 2019. -
News Cancer immunotherapies space to witness extraordinary growth
Several late-stage pipeline drugs are expected to achieve blockbuster status by the end of 2022, -
News Recipharm bolsters development business with new appointments in the US and Europe
CDMO appoints Anders Högdin and Aaron Small to lead the growth of its pharmaceutical development services business in the US and Europe. -
News Acousia Therapeutics receives EUR 2.5 M to develop innovative therapy to treat and prevent sensorineural hearing loss
New shareholder, Axxamof Milan, Italy, will transfer certain therapeutic assets to the R&D programs of Acousia. -
News Vetter's Skokie site successfully manufactures batches on new clinical syringe filling line
Additional storage expansion strengthens the facilities’ ability to meet increased customer demand in prefilled syringes. -
News BMS strengthens capabilities with evolution of its US geographic footprint
Company will also close its Hopewell, New Jersey site and will not renew its lease at the Lake Union Steam Plant site in Seattle, Washington. -
News FDA approves Synjardy XR tablets for adults with type 2 diabetes
New once-a-day formulation indicated to improve blood sugar when used along with diet and exercise. -
News Perrigo to restructure its Branded Consumer Healthcare business
Actions will help to improve the company's financial profile. -
News Alvogen launches the first generic equivalent to Tamiflu capsules in the US
Company expects the generic capsules will save up to $500 million during this upcoming season. -
News "Arctic blast" yields better lyophilisation results
Users of LyoSpeed on Series 3 HT Evaporators report a greater percentage of samples yield dry powders than they have previously been able to achieve. -
News Lonza confirms interest in Capsugel
Acquisition would "fit perfectly with Lonza's Healthcare Continuum strategy". -
News Demand for safe packaging to combat illicit drug market rackets on the rise
Pharma manufacturers are feeling encouraged to explore new possibilities. -
News Novartis' Lucentis received EU approval in new indication
Lucentis the only treatment available for a wide range of CNV conditions.
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