Policy & Regulation News
Policy & Regulation news
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News Pfizer announces EMA Acceptance for Review of MAA for Trumenba
The acceptance marks the beginning of the regulatory review process for this vaccine in the EU. -
News Rx-360 summary of FDA draft guidance on use of comparability protocols for CMC post-approval changes
Guidance is intended to establish a framework to promote continuous improvement in the manufacturing of quality products. -
News FDA grants Genentech’s cancer immunotherapy Tecentriq Accelerated Approval for people with a specific type of advanced bladder cancer
First and only anti-PDL1 cancer immunotherapy approved by the FDA. -
News Martindale Pharma expands European commercial activities to include France
Launch of early access programme for Noyada, first novel oral liquid formulation of Captopril targeting paediatric cardiovascular conditions and type 1 diabetic nephropathy. -
News Upcoming PDUFA and ANDA approval dates could catalyse Innovus Pharma and Lipocine
Investors may want to keep a close eye on both of these companies as key FDA response dates approach and PDUFA and ANDA decisions could serve as key catalysts for the stock price. -
News Alprolix (rFIXFc) approved in the EU for the treatment of haemophilia B
First Fc fusion therapy approved for haemophilia B in the EU to provide extended protection against bleeds. -
News BMS and AbbVie announce EC approval of Empliciti for the treatment of multiple myeloma in adults who have received at least one prior therapy
First and only immunostimulatory antibody approved in the European Union for multiple myeloma. -
News Pharmaceutical distribution supply chain pilot projects — FDA request for information
The information gathered from public comments will assist with the design and development of the pilot project(s) that FDA establishes under the DSCSA. -
News EC approves the first and only immuno-oncology combination, BMS's Opdivo + Yervoy Regimen, for treatment of advanced melanoma
Approval allows for the marketing of the Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen in all 28 Member States of the EU. -
News FDA grants Priority Review for Lilly's olaratumab, an investigational medicine for advanced soft tissue sarcoma
Lilly has received additional designations for olaratumab from the FDA, including Breakthrough Therapy, Fast Track and Orphan Drug, for this indication. -
News Endo announces US District Court ruling upholding Opana ER intellectual property
The ruling confirms the Court's prior injunction against the manufacture or sale of the generic version of non-crush-resistant Opana ER. -
News BASF welcomes EU approval for zinc oxide
After BASF’s Tinosorb A2B, Z-Cote is the second nano UV filter to be approved for use in cosmetics in Europe. -
News Allergan receives FDA approval of Crestor
First company to launch a generic version of Crestor to customers in the US. -
News FDA approves ACADIA Pharmaceuticals’ Nuplazid (pimavanserin)
The first drug approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. -
News Biogen and AbbVie receive Positive Opinion from the CHMP on Zinbryta for treatment of MS
Positive benefit-risk profile of Zinbryta supported by large head-to-head Phase III DECIDE study. -
News Novartis receives three FDA Breakthrough Therapy Designations for Ilaris to treat rare types of Periodic Fever Syndromes
Subject to approvals, Ilaris will likely be first FDA-approved treatment for TRAPS and HIDS/MKD, and an important alternative treatment for patients with FMF. -
News Fresenius Kabi issues voluntary nationwide recall of Sensorcaine-MPF (bupivacaine HCl) Injection
Visible particulate matter — glass — observed by the company of reserve samples. -
News BMS's Opdivo receives Breakthrough Therapy Designation from FDA for previously treated recurrent or metastatic squamous cell carcinoma of the head and neck
Designation signals the urgent need for new treatment approaches in recurrent or metastatic squamous cell carcinoma of the head and neck after platinum based therapy. -
News Shire Submits NDA to FDA for new formulation of Vyvanse CII as chewable tablets
New formulation, in adherence with approved indications, intended for children, adolescents and adults with difficulty swallowing or opening capsules. -
News AbbVie receives FDA accelerated approval of Venclexta (venetoclax) tablets
The first BCL-2 inhibitor in relapsed/refractory chronic lymphocytic leukemia patients with 17p deletion. -
News Synthon obtains approval for glatiramer acetate 20 mg/mL in Europe
Synthon is the only company to have performed such a study for glatiramer acetate and to obtain regulatory clearance in Europe. -
News FDA grants Priority Review for Genentech’s cancer immunotherapy atezolizumab in specific type of lung cancer
Treatment targets people with locally advanced or metastatic NSCLC whose disease expresses the protein PD-L1 and who have progressed on or after platinum-containing chemotherapy. -
News Hikma's ANDA for generic Advair Diskus accepted for filing by FDA
FDA has provided Hikma, through its wholly-owned subsidiary, West-Ward Pharmaceuticals, a GDUFA goal date of 10 May 2017. -
News Novartis receives EU approval for Revolade as first-in-class therapy for children aged 1 year and above with chronic ITP
Two formulations approved: once-daily tablet and oral suspension formulation designed for younger children who may not be able to swallow tablets. -
News NDA Group releases data comparing FDA and EMA ahead of annual DIA EuroMeeting in Hamburg
In spite of similar approval numbers, the US continue to outpace Europe. -
News GSK receives positive CHMP opinion in Europe for Strimvelis, the first gene therapy to treat very rare disease, ADA-SCID
The medicine is a stem cell gene therapy created for an individual patient from their own cells which is intended to correct the root cause of the disease. -
News Janssen receives CHMP Positive Opinion for Trevicta recommending approval in EU for maintenance treatment of schizophrenia
If approved, Trevica will be the first treatment for schizophrenia to be administered four times a year and will provide the longest dosing interval available for an antipsychotic medication in the EU. -
News OPKO receives Complete Response Letter from FDA for Rayaldee NDA
Sole issue relates to third-party manufacturing observations. -
News Flixabi, an infliximab biosimilar candidate referencing Remicade, receives positive CHMP opinion
Flixabi to be the second anti-TNF biosimilar commercialized and manufactured by Biogen in the EU. -
News EMA Validates BMS application for Opdivo for the treatment of classical Hodgkin lymphoma patients
Opdivo has potential to become first PD-1 inhibitor approved in a hematological malignancy in European Union. -
News SIR-Spheres Y-90 resin microspheres are a well-tolerated alternative to standard therapies for inoperable primary liver cancer, says new UK NICE MIB
Unlike TACE, most patients treated with SIR-Spheres Y-90 resin microspheres usually require only a single treatment. -
News Shire wins patent trial against Watson concerning Lialda
Lialda patent upheld and extends through 8 June 2020. -
News Takeda and Lundbeck receive Complete Response Letter for Brintellix (vortioxetine) sNDA
Lack of clinical trial data to support a claim of effectiveness for Brintellix in treating certain aspects of cognitive dysfunction in adults with MDD. -
News EMA accepts for review Pfizer's MAA for Xeljanz for the treatment of moderate to severe rheumatoid arthritis
Application provides additional information to the original MAA submission, including data from the Phase III ORAL global development program in RA. -
News FDA approves Teva's Cinqair (reslizumab) Injection
New biologic for add-on maintenance treatment in adults with severe asthma and an eosinophilic phenotype. -
News Eisai withdraws NDA for mecobalamin ultra-high dose preparation as treatment for ALS
The application package submitted was not sufficient for approval. -
News Akers Biosciences allowed US Patent for heparin/PF4 antibody detection
The newly allowed Patent covers Akers Bio's proprietary protein preparation which serves as the antigen and biologically active component of the tests. -
News Lilly's Taltz receives FDA approval for the treatment of moderate-to-severe plaque psoriasis
In pivotal studies, most patients treated with Taltz achieved significant skin clearance with many achieving virtually clear or completely clear skin at week 12. -
News Eagle Pharmaceuticals receives Complete Response Letter from FDA on Kangio application
FDA requests further characterization of bivalirudin-related substances in the drug product. -
News RedHill Biopharma announces positive FDA meeting on RHB-105 path to approval and planned confirmatory Phase III study for H. pylori infection
The FDA has confirmed, subject to final minutes of the meeting, the planned two-arm, randomized, double-blind, active comparator design of the confirmatory Phase III study with RHB-105 for the treatment of H. pylori infection, expected to be initiated ... -
News Allergan confirms generic Abraxane patent challenge
The company believes it is a "first applicant" to file an ANDA for the generic version of Abraxane. -
News FDA grants Genentech’s cancer immunotherapy atezolizumab Priority Review for advanced bladder cancer
FDA will make a decision on approval by 12 September 2016. -
News FDA approves Xalkori for the treatment of patients with ROS1-positive metastatic NSCLC
Xalkori is the first and only FDA-approved biomarker-driven therapy for ROS1-positive metastatic NSCLC. -
News EMA reviews cancer medicine Zydelig
Review follows concerns over serious adverse events in ongoing clinical trials. -
News FDA issues a draft guidance for industry on Implementation of the ‘Deemed to be a License’ Provision of the BPCI Act of 2009
The draft guidance explains that FDA will not approve any pending or tentatively approved application for a biological product under the FD&C Act after 23 March 2020. -
News Allergan Receives Complete Response Letter from FDA for Prior Approval Supplement for Restasis 0.05% Multi-Dose Preservative-Free bottle
FDA requested additional CMC information for the Multi-Dose Preservative-Free bottle. -
News EMA launches PRIME — paving the way for promising medicines for patients
New scheme supports European Commission priorities. -
News FDA accepts sBLA for Keytruda (pembrolizumab) in advanced NSCLC
Application based on data from KEYNOTE-010, which showed superior overall survival for patients taking Keytruda compared to chemotherapy in patients with PD-L1 expression on one percent or more of the cancer cells. -
News Imbruvica (ibrutinib) approved by FDA for the first-line treatment of chronic lymphocytic leukemia
First FDA-approved chemotherapy-free treatment option for first-line CLL patients. -
News FDA approves new indication for Faslodex (fulvestrant)
Approval expands use and offers additional option for women with HR+, HER2- metastatic breast cancer. -
News Sartorius Stedim BioOutsource contract testing facility in Glasgow successfully passes FDA inspection
Certified quality of analytical services for developers of biologics and biosimilars . -
News Amgen submits sBLA for Blincyto (blinatumomab)
Filing based on Phase II study showing Blincyto provides meaningful therapeutic benefits in difficult-to-treat type of pediatric acute lymphoblastic leukemia. -
News Sobi and Biogen receive positive opinion from CHMP for Alprolix (rFIXFc) for the treatment of hemophilia B
If approved, Alprolix would be among the first therapies in the European Union (EU) to offer people living with hemophilia B prolonged protection against bleeding episodes with prophylactic dosing intervals. -
News True North Therapeutics receives Orphan Drug Designation in the EU for TNT009 for the treatment of autoimmune hemolytic anemia, including CAD
Top-line Phase Ib data in patients with CAD expected in mid-2016. -
News FDA approves new indication for Novartis drug Afinitor for progressive, nonfunctional GI and lung neuroendocrine tumours
In advanced progressive, nonfunctional NET, Afinitor is the first approved treatment for patients with lung NET and the first oral therapy for GI NET. -
News FDA approves Genentech’s Gazyva for certain people with previously treated follicular lymphoma
This is the second FDA approval for Gazyva based on a positive Phase III study. -
News FDA accepts and grants Priority Review for Avycaz sNDA
Application seeks to expand Avycaz label to include Phase III clinical data for the treatment of complicated intra-abdominal infections , in combination with metronidazole. -
News FDA accepts Sanofi NDA for once-daily fixed-ratio combination of insulin glargine and lixisenatide
FDA decision anticipated in August 2016. -
News Mylan's ANDA for generic Advair Diskus accepted for filing by FDA
FDA provides GDUFA goal date of 28 March 28 2017 -
News Pfizer receives expanded FDA approval for Ibrance in HR+, HER2- metastatic breast cancer
First-in-class therapy now approved for use in a broader range of women. -
News Novartis drug PKC412 receives Breakthrough Therapy designation from FDA for newly-diagnosed FLT3-mutated AML
PKC412 (midostaurin) significantly improved overall survival of adult patients eligible to receive standard induction and consolidation chemotherapy. -
News Rx-360 summary of the FDA proposed rule for combination products
The proposed rule would harmonize the requirements for prescription and nonprescription products. -
News Impax receives FDA approval for generic version of Adderall XR capsules, CII
Company due to supply its ANDA product during the second quarter of 2016. -
News UK court rules against Lilly in Alimta vitamin regimen patent lawsuit
Lilly plans to seek permission to appeal the ruling. -
News Merck receives Complete Response Letter from FDA for Zetia (ezetimibe) and Vytorin (ezetimibe and simvastatin)
The company is reviewing the letter and will determine next steps. -
News JHL Biotech receives approval From European authorities to begin biosimilar clinical trial
First biotech company in Greater China region to receive European approval. -
News CMA fines pharma companies £45 million
The CMA has fined a number of pharmaceutical companies for anti-competitive conduct and agreements in relation to the supply of paroxetine. -
News Sandoz advances its biosimilars program with EMA acceptance of regulatory submission for biosimilar pegfilgrastim
Sandoz's late-stage biosimilar pipeline gains momentum with sustained investment - five of 10 planned regulatory filings achieved. -
News Shire partner, Shionogi, submits NDA in Japan for ADHD treatment for children
With submission, Shire continues to strengthen its presence in Japan. -
News Pfizer commends FDA Advisory Committee’s vote to approve proposed biosimilar infliximab
The first biosimilar monoclonal antibody reviewed, for all eligible indications. -
News FDA approves expanded use of BMS’s Daklinza
Updated label provides new treatment option for patients with HIV-1 coinfection, advanced cirrhosis, and post-liver transplant HCV recurrence. -
News Oasmia submits MAA to the EMA for its lead cancer product Apealea
The indication sought for Apealea is treatment of epithelial ovarian cancer in combination with carboplatin. -
News First immunotherapy EAMS for most common type of lung cancer brings UK patients access to life-extending medicine
MHRA grants UK lung cancer patients access to BMS's nivolumab. -
News Vertex receives Complete Response Letter from FDA regarding Kalydeco
Company plans to meet with FDA to determine appropriate path forward. -
News Merck set to launch new version of fertility pens
EMA approves Merck's GONAL-f prefilled pen 2.0. -
News Rx-360 summary of the EMA work plan for GMP/GDP Inspectors Working Group for 2016
Highlights include inspections, MRAs, harmonization efforts amd GMP/GDP guidance. -
News Rx-360 summary of WHO supplementary guidelines on GMP for HVAC systems for non-sterile pharmaceuticals
These guidelines primarily focus on recommendations for systems for manufactures of solid dosage forms. -
News BMS and AbbVie receive positive CHMP opinion for investigational antibody, Empliciti, for the treatment of multiple myeloma
Positive opinion based on reduction in the risk of disease progression or death with Empliciti in combination with standard of care regimen for multiple myeloma demonstrated in ELOQUENT-2 study. -
News Merck announces FDA acceptance of BLA for bezlotoxumab, an investigational antitoxin for prevention of Clostridium difficile infection recurrence
FDA grants Priority Review with target action date of 23 July 23 2016. -
News Shire resubmits NDA for lifitegrast to FDA
Resubmission includes positive data from OPUS-3, a Phase III efficacy and safety trial. -
News FDA accepts filing of cardiovascular outcomes data for Jardiance
Boehringer Ingelheim and Eli Lilly and Company expect to receive a decision from the FDA within the standard review time frame. -
News Valeant announces FDA acceptance of BLA submission for brodalumab in moderate-to-severe plaque psoriasis
The brodalumab BLA is supported by data from the three AMAGINE Phase III pivotal studies. -
News BMS's Opdivo + Yervoy regimen receives expanded FDA approval
Opdivo + Yervoy Regimen now indicated for unresectable or metastatic melanoma patients, regardless of BRAF mutational status, based on accelerated approval. -
News FDA approves Botox for the treatment of lower limb spasticity in adults
Botox is the first and only FDA-approved neurotoxin treatment for both upper and lower limb spasticity. -
News NICE ‘yes’ for Opdivo offers patients with advanced skin cancer new treatment option
NHS patients in England and Wales will be able to access an innovative treatment option that offers a potentially rapid and durable response in patients with previously untreated advanced melanoma, compared with chemotherapy. -
News Lilly and Incyte submit NDA to FDA for oral once-daily baricitinib
Baricitinib is for the treatment of moderate-to-severe rheumatoid arthritis. -
News Mylan launches generic Felbatol tablets
Recommended for monotherapy or adjunctive therapy in the treatment of partial seizures. -
News Benepali, the first etanercept biosimilar referencing Enbrel, approved in the EU
Biogen will manufacture and commercialize Benepali in the EU. -
News FDA grants Priority Review for venetoclax NDA
Venetoclax, an investigational medicine, is a potential new way of treating the most common adult leukemia. -
News Epigenomics receives FDA notification about status of pending approval decision for Epi proColon
Final approval of the company's application is subject to the resolution of minor outstanding topics, such as the use of appropriate language in the product labeling. -
News Regeneron and Sanofi announce sarilumab BLA Accepted for review by FDA
Sarilumab is an investigational, human monoclonal antibody intended for the treatment of patients with active, moderate-to-severe rheumatoid arthritis -
News Teikoku Pharma USA, Inc. announces FDA approval of docetaxel injection
First non-alcohol formulation approved in the US. -
News Actelion receices FDA approval of Uptravi for the treatment of pulmonary arterial hypertension
Uptravi will be made available to patients in the US in early January 2016. -
News FDA warns of potential contamination of drug shipments from explosions in Tianjin City
The increased surveillance resulted in the detection of hydrogen cyanide contamination in two shipments of drugs from Tianjin Tianyao Pharmaceuticals Co., Ltd. -
News Sun Pharma receives Warning Letter for Halol facility
Company makes significant investments in automation and training to enhance its Quality Systems -
News Boehringer Ingelheim's third generation EGFR TKI, BI 1482694, receives FDA Breakthrough Therapy Designation for treatment of patients with NSCLC
FDA designation reinforces potential for BI 1482694 to become a new treatment option for patients with EGFR mutation-positive lung cancer with a T790M mutation. -
News Green light for reliance on Article 57 database for key pharmacovigilance information on medicines for human use in Europe
As of 1 February 2016, for both centrally and nationally authorised medicines, companies will no longer be required to submit type IA variations in relation to the Qualified Person Responsible for Pharmacovigilance and Pharmacovigilance System Master F... -
News FDA Draft Guidance: Safety Assessment for IND Safety Reporting
The FDA has published draft guidance for sponsors of investigational new drug application (IND) studies with recommendations for identifying and evaluating important safety information that must be submitted to FDA and all participating investigators u... -
News FDA approves Basaglar (insulin glargine injection), a long-acting insulin treatment
Basaglar is the first FDA-approved follow-on insulin glargine treatment. -
News A Practical Guide to Writing Risk Management Plans
Research and Markets has announced the addition of the "A Practical Guide to Writing Risk Management Plans (RMPS) (London, UK — 25 January 2016)" conference to their offering. -
News NICE ‘no’ for Opdivo, could deny some lung cancer patients one of the most significant advances in almost 20 years
The draft decision specifically affects adult patients with locally advanced or metastatic squamous non-small cell lung whose disease has progressed after prior chemotherapy. -
News Rx-360 summary of PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE-009-12)
The Guide covers GMP principles and active substances used as starting materials. -
News FDA approves Kanuma for the treatment of patients with lysosomal acid lipase deficiency
Kanuma is the first approved treatment in the US for patients suffering from LAL-D, a life-threatening and ultra-rare metabolic disorder. -
News Novo Nordisk files for regulatory approval of faster-acting insulin aspart in the EU for the treatment of type 1 and 2 diabetes
The company intends to make faster-acting insulin aspart available in the prefilled delivery device FlexTouch. -
News Merck Announces Samsung Bioepis receives approval of Renfelxis (infliximab), a biosimilar of Remicade, in Korea
Samsung Bioepis’ second immunology biosimilar approved, to be commercialized under partnership with Merck -
News Sun Pharma receives FDA approval for generic Gleevec
Company eligible for 180-days marketing exclusivity on a first-to-file Para-IV ANDA. -
News Amgen's first biosimilar marketing authorization application submitted to EMA for ABP 501
Supported by Phase III studies in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. -
News Baxalta receives CHMP positive opinion for Sanquin to begin production, enhancing global supply of plasma-based therapies
Sanquin is now licensed to produce bulk material for HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] and GAMMAGARD LIQUID 10% [Immune Globulin Infusion (Human)] (marketed as KIOVIG in the EU) for the European Union, I... -
News Health Canada approves Jardiance tablets for adults with type 2 diabetes
Jardiance lowers the renal threshold for glucose, which leads to reduced renal reabsorption of filtered glucose and increased urinary glucose excretion. -
News FDA approves Portrazza for specific type of lung cancer
Portrazza, in combination with gemcitabine and cisplatin, is the first biologic approved for first-line treatment of people with metastatic squamous non-small cell lung cancer. -
News Epigenomics appeals recent FDA request for additional information
Company believes that an approval for the intended use of Epi proColon is warranted based on the data that has been submitted to date. -
News Ready for the change? — PTI provides guidance on new EU Clinical Trial Regulation
The EU-CTR replaces the EU Clinical Trials Directive and is designed to improve harmonisation on conducting clinical trials of medicinal products for human use throughout the EU. -
News Amgen's first biosimilar Biologics License Application for ABP 501 submitted To FDA
Supported by Phase III studies in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. -
News Impax receives European Commission marketing authorization for Numient modified-release capsules for the symptomatic treatment of adults with Parkinson's disease
The company’s first branded drug approval outside of the US. -
News Merck and Pfizer receive positive opinion for ODD for avelumab in Merkel cell carcinoma from EMA COMP
EMA ODD is an important regulatory milestone for avelumab in metastatic Merkel cell carcinoma (MCC). -
News FDA approves Takeda's Ninlaro, the first and only oral proteasome inhibitor to treat multiple myeloma
Ninlaro provides a new option for patients living with multiple myeloma who have received at least one prior therapy. -
News BMS receives FDA approval for Opdivo, the only treatment to deliver significant overall survival in advanced renal cell carcinoma
Fifth approval for Opdivo in 12 months. -
News FDA moves quickly to approve easy-to-use nasal spray to treat opioid overdose
Naloxone in nasal spray form provides important new alternative for family members, first responders. -
News Biogen announces Benepali (etanercept) is the first biosimilar of Enbrel to receive a positive opinion from CHMP
Pending EC approval, Biogen would commercialize Benepali in the EU.
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