Policy & Regulation News
Policy & Regulation news
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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 FDA accepts for filing sNDA for Liletta 52 mg
Application seeks to extend duration of use up to 4 years for Liletta. -
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 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 FDA approves first drug for spinal muscular atrophy
Spinraza improved motor function in SMA patients. -
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 pill available on the NHS for patients suffering with psoriatic arthritis
Oral Otezla receives positive NICE recommendation for adults with psoriatic arthritis. -
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 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 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 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 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 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 Novartis' Lucentis received EU approval in new indication
Lucentis the only treatment available for a wide range of CNV conditions. -
News Mederi's Stretta Therapy for GERD approved in China
Clinically proven and cost-effective solution for gastroesophageal reflux disease recently launched in China. -
News Pfizer refutes the findings set out in the CMA decision
Pharma giant says it complied with established competition law. -
News FDA approves Jardiance tablets to reduce the risk of cardiovascular death in adults with T2D
The only oral T2D medicine to provide a life-saving cardiovascular benefit. -
News FDA accepts BLA for avelumab for the treatment of metastatic MCC for Priority Review
If approved by the FDA, avelumab could be the first treatment indicated for patients with metastatic Merkel cell carcinoma. -
News European Commission approves BMS's Opdivo for Hodgkin's
Opdivo is now the first and only PD-1 inhibitor approved for a hematologic malignancy in the European Union. -
News NICE ‘yes’ to Imnovid in the fight against the biggest blood cancer killer in the UK
Pomalidomide available to people in England immediately via the Cancer Drugs Fund. -
News FDA gives green light to Sanofi's once-daily Soliqua 100/33
The type 2 diabetes treatment for adults will be delivered using SoloStar technology. -
News Allergan receives FDA clearance for the XEN Gel Stent
The XEN Glaucoma Treatment System reduces intraocular pressure in patients with refractory glaucoma. -
News GSK receives FDA approval for expanded indication for FluLaval Quadrivalent
Indication now includes use in children 6 months and older. -
News Intarcia's NDA tackles glycemic control and poor patient adherence head on
ITCA 650 is the first investigational drug to use Intarcia's disruptive Medici Drug Delivery System to deliver chronic medicines just once or twice yearly. -
News NICE ‘yes’ for chronic myeloid leukaemia pill
For patients this could mean more are able to achieve a normal life expectancy, without compromising on their quality of life. -
News Adherium’s Smartinhaler dramatically improves clinical outcomes and medication adherence in children with asthma
Trial results also provide a cost-saving argument for introducing Smartinhaler into routine practice. -
News Xellia Pharmaceuticals receives green light from FDA to commence packaging and distribution operations at Cleveland site
Company prepares to start the production of sterile anti-infective injectable products at this site during 2018. -
News EC approves Parsabiv for the treatment of secondary hyperparathyroidism in adults on hemodialysis
First treatment advance for secondary hyperparathyroidism in more than a decade. -
News Sanofi receives CHMP recommendation for approval of Suliqua in the EU
Treatment combines two widely used and complementary medicines into a single daily injection for people with type 2 diabetes who are struggling to keep their blood sugar levels under control. -
News BMS's Opdivo is the first immuno-oncology treatment to receive FDA approval
Treatment proven in a Phase III trial to significantly extend overall survival for patients with recurrent or metastatic squamous cell head and neck cancer. -
News Mylan and Biocon announce FDA submission for proposed biosimilar trastuzumab
Potential to be first submission of a proposed biosimilar trastuzumab in the US. -
News SMC ‘yes’ to first immunotherapy combination for skin cancer patients
Allows adult patients with advanced melanoma to receive first-line treatment with the potentially life-extending combination therapy of Opdivo (nivolumab) and Yervoy (ipilimumab) on the NHS in Scotland. -
News Mylan and Biocon announce regulatory submission for insulin glargine accepted for eeview by EMA
Filing includes analytical, functional and pre-clinical data, and results from the pharmacokinetics and confirmatory efficacy/safety global clinical trial in Type 2 diabetes patients comparing Mylan's and Biocon's Insulin glargine with Lantus. -
News Positive NICE recommendation for Halaven for patients with locally advanced or metastatic breast cancer
Is the first breast cancer treatment to be recommended by NICE in nearly a decade. -
News Novartis LEE011 granted FDA Priority Review for first-line treatment of HR+/HER2- advanced breast cancer
Trial showed LEE011 plus letrozole reduced the risk of progression or death by 44% over letrozole alone. -
News AmpliPhi Biosciences granted Small and Medium Enterprise status by EMA
Europe to be a key market for the company's phage-based therapies to treat bacterial infections in patients with unmet medical needs. -
News EMA validates the MAA for avelumab for the treatment of metastatic Merkel cell carcinoma
If approved, avelumab, an investigational anti-PD-L1 IgG1, could be the first treatment indicated for patients with metastatic Merkel cell carcinoma. -
News Regeneron and Sanofi receive Complete Response Letter from FDA for sarilumab
Deficiencies identified during a routine good manufacturing practice inspection of the Sanofi Le Trait facility in France where sarilumab is filled and finished. -
News Clobazam oral suspension approved in seven European countries
Provides pan-European availability of widely used and much needed oral liquid version clobazam tablets. -
News FDA approves Merck’s Keytruda in metastatic NSCLC
Approval is for first-line treatment of patients whose tumours have high PD-L1 expression with no EGFR or ALK genomic tumour aberrations. -
News FDA approves sNDA for Xtandi capsules in advanced prostate cancer
Data demonstrate improvement in radiographic progression-free survival in patients with metastatic castration-resistant prostate cancer who were treated with enzalutamide compared to patients who were treated with bicalutamide. -
News FDA approves Genentech’s cancer immunotherapy Tecentriq for people with a specific type of metastatic lung cancer
First and only anti-PDL1 cancer immunotherapy approved by the FDA for metastatic non-small cell lung cancer. -
News CHMP adopts positive opinion of metformin
Includes Merck’s type 2 diabetes treatment portfolio, in patients with renal impairment. -
News Allergan's Belkyra receives marketing authorisation in Sweden
Marketing authorization given for the treatment of moderate to severe fullness under the chin. -
News FDA grants Orphan Drug Designation for True North Therapeutics' lead product candidate, TNT009
TNT009 is currently in clinical development for the treatment of autoimmune hemolytic anemia, including Cold Agglutinin Disease (CAD), a form of autoimmune hemolytic anemia. -
News Arch Biopartners receives patent for Metablok
Is the first patent issued protecting the composition and method of use for Metablok, the company's drug candidate targeting inflammation, sepsis and cancer metastasis. -
News FDA accepts sNDA for Avycaz
Application seeks to expand Avycaz label to include Phase III clinical data for the treatment of complicated urinary tract infections. -
News FDA approvs infant-specific dose of Pertzye delayed-release capsules to treat EPI due to cystic fibrosis
The new formulation will be offered in 4,000 lipase units capsule. -
News Patent trial and appeal board upholds the validity of Lialda patent
Shire pleased with the decision and will continue to vigorously defend its patents. -
News Theratechnologies to move forward with development of new single vial formulation for Egrifta
The introduction of a single vial presentation was part of commitments required by the FDA when it approved Egrifta (Tesamorelin for Injection). -
News Biogen completes rolling submission of NDA to FDA for nusinersen as a treatment for spinal muscular atrophy
Submission of Marketing Authorization Application to the EMA planned in the coming weeks. -
News FDA approves Amgen's new biosimilar for multiple inflammatory diseases
Amjevita is the first adalimumab biosimilar approved by the FDA and has been approved for the treatment of seven inflammatory diseases. -
News Novartis receives three new FDA approvals for the expanded use of Ilaris
Ilaris is the first and only US FDA-approved biologic treatment for patients with TRAPS, HIDS/MKD and FMF disease. -
News EMA validates BMS’s type II variation application for Opdivo in advanced form of bladder cancer
Extends the current indications for Opdivo to include the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy. -
News FDA grants accelerated approval to first drug for Duchenne muscular dystrophy
Approval given to EXONDYS 51 (eteplirsen) as a once weekly intravenous infusion of 30 mg/kg for the treatment of DMD in patients who have a confirmed mutation in the DMD gene that is amenable to exon 51 skipping. -
News District Court issues ruling in Hatch Waxman Case regarding Shire’s Lialda
Shire to consider appeal. -
News Glyxambi approval recommended by CHMP for adults with type 2 diabetes in the EU
Glyxambi is a single tablet that combines Jardiance and Trajenta and has been shown to improve blood sugar control in adults with type 2 diabetes. -
News Santalis Pharmaceuticals issued patent for the use of sandalwood oil to treat cancers
Patent covers East Indian sandalwood oil-containing compositions that can be used to treat a variety of cancers. -
News Dechra receives FDA approval for first US generic entrant antibiotic
Is the first registration Dechra has achieved through Putney's development pipeline since it acquired the US-based business -
News Orphan Drug Designation granted to nintedanib for treatment of systemic sclerosis
Designation also includes the associated interstitial lung disease. -
News Lilly and AstraZeneca receive FDA Fast Track designation for AZD3293
AZD3293 is an investigational treatment for early Alzheimer's disease -
News Indian FDA approves Innovus Pharma's Zestra, Zestra Glide, EjectDelay and Sensum+
Products now approved in seven countries. -
News Portola Pharmaceuticals announces validation of MAA by EMA for IndexXa a Factor Xa inhibitoraAntidote
EMA's CHMP to begin centralized review procedure. -
News Portola Pharmaceuticals receives CRL for BLA for AndexXa
Agency request additional information primarily related to manufacturing. -
News FDA issues import alert for all drugs produced by Laxachem Organics in India
Decision taken after company refuses to allow FDA facility inspection. -
News Merck announces FDA filing acceptance of NDA for MK-1293, an investigational follow-on biologic insulin glargine
Marketing Authorization Application to the EMA currently under review. -
News FDA approves Merck’s Keytruda for patients with recurrent or metastatic HNSCC
New treatment option for patients with with disease progression on or after platinum-containing chemotherapy. -
News FDA approves first generic version of influenza drug
Natco receives approval for generic Tamiflu. -
News FDA approves Flonase Sensimist Allergy Relief
Another Rx-to-OTC Switch from GSK Consumer Healthcare to help allergy sufferers find more complete relief. -
News Novartis CDK4/6 inhibitor LEE011 receives FDA Breakthrough Therapy designation
LEE001 potential first-line treatment for HR+/HER2- advanced breast cancer. -
News EMA accepts for review the Marketing Authorisation Application for sarilumab
Sarilumab is an investigational human monoclonal antibody directed against the IL-6 receptor that is intended for the treatment of adult patients with moderately to severely active rheumatoid arthritis. -
News Sunovion submits NDA for SUN-101/eFlow to FDA for the treatment of patients with COPD
If approved, SUN-101/eFlow will be the first nebulized long-acting muscarinic antagonist (LAMA) for the long-term, maintenance treatment of airflow obstruction in patients with COPD. -
News Shire’s SHP626 (volixibat) receives FDA fast track designation
Designation is for an investigational treatment of adults who have nonalcoholic steatohepatitis (NASH) with liver fibrosis. -
News Sanofi receives FDA approval of Adlyxin for treatment of adults with type 2 diabetes
Adlyxin is approved as Lyxumia in more than 60 countries. -
News Ocular Therapeutix receives CRL from FDA for its NDA for Dextenza
FDA reports deficiencies in manufacturing process and controls identified during a pre-NDA approval inspection of the Ocular Therapeutix manufacturing facility. -
News Allergan receives Positive Opinion For Truberzi for treatment of IBS-D in adults
Significant step towards bringing the only licensed prescription medication for IBS-D to patients in 28 countries of the EU. -
News FDA grants QIDP and Fast Track designations to MCB3837
Morphochem’s novel intravenous antibacterial to treat C. difficile infections. -
News Amgen and UCB submit BLA for romosozumab to the FDA
Based on Phase III FRAME Study in postmenopausal women with osteoporosis. -
News FDA expands indication for type 2 diabetes treatment Synjardy
Expanded indication now includes treatment-naïve adults. -
News SB5, an adalimumab biosimilar referencing Humira, accepted for review by EMA
The approval of SB5 could make Biogen the first company to commercialize three anti-TNF biosimilar therapies in Europe. -
News Allergan files application to FDA for approval of Oculeve Intranasal Tear Neurostimulator
A first of its kind approach to increasing tear production in patients suffering from dry eye disease. -
News Sandoz biosimilar etanercept recommended by FDA advisory committee for approval to treat multiple inflammatory diseases
Committee votes unanimously in favor of the Sandoz proposed biosimilar etanercept for all approved indications of the reference product. -
News Pfizer receives FDA approval for Prevnar 13 in adults age 18 through 49
Prevnar 13 is the only pneumococcal vaccine approved in the US for patients 6 weeks through adulthood. -
News FDA Approves Shire’s Xiidra
Xiidra is the only treatment Indicated for the signs and symptoms of dry eye disease. -
News Scots first to receive breakthrough immunotherapy for lung cancer
Eligible patients in Scotland will be the first in the UK to access this life-extending treatment and will be ahead of those patients in England and Wales. -
News FDA approves first and only single monthly injection for a PCSK9 inhibitor
Amgen's Repatha (evolocumab) Pushtronex system (on-body infusor with prefilled cartridge) provides a new, monthly single-dose administration option. -
News EC grants marketing authorization for Gilead’s Epclusa for the treatment of all genotypes of chronic hepatitis C
Epclusa is the first and only all-oral, single tablet regimen for all genotypes (1-6) of chronic hepatitis C virus infection and is Gilead’s third Sofosbuvir-based treatment. -
News FDA approves Genentech’s Xolair for allergic asthma in children
Approval makes Xolair the only biologic for children ages six and up with uncontrolled allergic asthma. -
News Shire receives extension of Market Authorization in Europe for Revestive
First therapy indicated in the EU for use in patients aged one year and above with Short Bowel Syndrome, a rare gastrointestinal condition. -
News EC approves extended indication for Amgen's Kyprolis
Head-to-head Phase III trial demonstrated superiority of Kyprolis and dexamethasone over Velcade and dexamethasone in patients with relapsed multiple myeloma. -
News Chinese authorities issue operating approval to Siegfried Nantong
This significant site addition to Siegfried’s production network strengthens the company’s long-term competitiveness. -
News FDA Advisory Committee recommends approval of Jardiance for cardiovascular indication
Endocrinologic and Metabolic Drugs Advisory Committee votes in favour of cardiovascular mortality benefit for JARDIANCE for adults with type 2 diabetes. -
News BMS Opdivo receives Breakthrough Therapy Designation from FDA for advanced form of bladder cancer
This milestone marks the sixth Breakthrough Therapy Designation for Opdivo. -
News Allergan announces FDA approval of sNDA for Avycaz
Label now includes Phase III clinical data evaluating the safety and efficacy of Avycaz (in combination with metronidazole) in patients with complicated intra-abdominal infections. -
News Mylan launches generic Avodart Capsules
Product is indicated as monotherapy for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention and reduce the risk of the need for BPH-related sur... -
News EMA starts review of medicines manufactured at Pharmaceutics International Inc.
Shortcomings include insufficient measures to reduce the risk of cross-contamination, as well as quality assurance. -
News OPKO’S Rayaldee product receives FDA approval
First drug to use Catalent’s proprietary OptiShell capsule technology to achieve extended release profile. -
News PaizaBio: China approves Drug Marketing Authorization Holder pilot plan
Move approves the use of contract manufacturing organisations. -
News Breakthrough combination for patients with skin cancer receives fast-tracked ‘yes’ from NICE
This represents one of the fastest ever approvals by NICE – UK patients will be the first to benefit across Europe. -
News NICE denies NHS patients access to Vertex's Orkambi
“As a result of applying the wrong appraisal process, approximately 2,700 people in England who could benefit from Orkambi are being forced to continue waiting for access.” -
News Rx-360 summary of the draft WHO HVAC GMPs for non-sterile products
Document is intended to provide guidance to pharmaceutical manufacturers and inspectors of pharmaceutical manufacturing facilities on the design, installation, qualification and maintenance of the HVAC systems. -
News Health Canada approves Inflectra (biosimilar infliximab) for three additional indications
The addition of Crohn's disease, fistulising Crohn's disease and ulcerative colitis to the approved indications was granted on the basis of similarity between Inflectra and the reference product, Remicade. -
News FDA approves Vaxchora, PaxVax’s single-dose oral cholera vaccine
Vaxchora is the only approved vaccine in the US for protection against cholera. -
News FDA accepts for review Ironwood and Allergan's sNDA for 72 mcg linaclotide in CIC
The FDA Prescription Drug User Fee Act target action date is expected to occur in early 2017. -
News FDA targets unlawful internet sales of illegal prescription medicines during international operation Pangea IX
FDA has requested the suspension of 4,402 websites and has issued warning letters to the operators of 53 websites illegally offering unapproved and misbranded prescription drug products for sale to US consumers. -
News FDA approves once-daily Jentadueto XR Tablets for adults with type 2 diabetes
New formulation of medicines that helps lower blood sugar in type 2 diabetes can be taken once a day. -
News Flixabi, Biogen’s infliximab biosimilar referencing Remicade, approved in the EU
Biogen to manufacture and commercialize Flixabi, the company’s second anti-TNF biosimilar therapy in the EU. -
News Merck receives positive CHMP opinion for Zepatier (elbasvir and grazoprevir) in the EU
Product launches estimated to begin in the fourth quarter of 2016 or the first quarter of 2017. -
News Amgen receives positive CHMP opinion to extend indication of Kyprolis for the treatment of relapsed multiple myeloma
Pivotal head-to-head ENDEAVOR study shows Kyprolis plus dexamethasone doubled progression-free survival compared to Velcade (Bortezomib) and dexamethasone. -
News DCGI gives limited approval to market FIRST Allogeneic cell therapy product in India
Stempeutics puts India on the 'World map of Regenerative Medicine'. -
News BioPharma Services USA awarded a 5 Year, $20 million contract with the FDA
The contract is to conduct in vivo studies of generic drug products in human subjects from 2016 through to 2021.
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