Policy & Regulation News

Pivotal head-to-head ENDEAVOR study shows Kyprolis plus dexamethasone doubled progression-free survival compared to Velcade (Bortezomib) and dexamethasone.

Stempeutics puts India on the 'World map of Regenerative Medicine'.

The contract is to conduct in vivo studies of generic drug products in human subjects from 2016 through to 2021.

The acceptance marks the beginning of the regulatory review process for this vaccine in the EU.

Guidance is intended to establish a framework to promote continuous improvement in the manufacturing of quality products.

First and only anti-PDL1 cancer immunotherapy approved by the FDA.

Launch of early access programme for Noyada, first novel oral liquid formulation of Captopril targeting paediatric cardiovascular conditions and type 1 diabetic nephropathy.

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.

First Fc fusion therapy approved for haemophilia B in the EU to provide extended protection against bleeds.

First and only immunostimulatory antibody approved in the European Union for multiple myeloma.

The information gathered from public comments will assist with the design and development of the pilot project(s) that FDA establishes under the DSCSA.

Approval allows for the marketing of the Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen in all 28 Member States of the EU.

Lilly has received additional designations for olaratumab from the FDA, including Breakthrough Therapy, Fast Track and Orphan Drug, for this indication.

The ruling confirms the Court's prior injunction against the manufacture or sale of the generic version of non-crush-resistant Opana ER.

After BASF’s Tinosorb A2B, Z-Cote is the second nano UV filter to be approved for use in cosmetics in Europe.

First company to launch a generic version of Crestor to customers in the US.

The first drug approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

Positive benefit-risk profile of Zinbryta supported by large head-to-head Phase III DECIDE study.

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.

Visible particulate matter — glass — observed by the company of reserve samples.

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.

New formulation, in adherence with approved indications, intended for children, adolescents and adults with difficulty swallowing or opening capsules.

The first BCL-2 inhibitor in relapsed/refractory chronic lymphocytic leukemia patients with 17p deletion.

Synthon is the only company to have performed such a study for glatiramer acetate and to obtain regulatory clearance in Europe.

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.

FDA has provided Hikma, through its wholly-owned subsidiary, West-Ward Pharmaceuticals, a GDUFA goal date of 10 May 2017.

Two formulations approved: once-daily tablet and oral suspension formulation designed for younger children who may not be able to swallow tablets.

In spite of similar approval numbers, the US continue to outpace Europe.

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.

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.

Sole issue relates to third-party manufacturing observations.

Flixabi to be the second anti-TNF biosimilar commercialized and manufactured by Biogen in the EU.

Opdivo has potential to become first PD-1 inhibitor approved in a hematological malignancy in European Union.

Unlike TACE, most patients treated with SIR-Spheres Y-90 resin microspheres usually require only a single treatment.

Lialda patent upheld and extends through 8 June 2020.

Lack of clinical trial data to support a claim of effectiveness for Brintellix in treating certain aspects of cognitive dysfunction in adults with MDD.

Application provides additional information to the original MAA submission, including data from the Phase III ORAL global development program in RA.

New biologic for add-on maintenance treatment in adults with severe asthma and an eosinophilic phenotype.

The application package submitted was not sufficient for approval.

The newly allowed Patent covers Akers Bio's proprietary protein preparation which serves as the antigen and biologically active component of the tests.

In pivotal studies, most patients treated with Taltz achieved significant skin clearance with many achieving virtually clear or completely clear skin at week 12.

FDA requests further characterization of bivalirudin-related substances in the drug product.

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 ...

The company believes it is a "first applicant" to file an ANDA for the generic version of Abraxane.

FDA will make a decision on approval by 12 September 2016.

Xalkori is the first and only FDA-approved biomarker-driven therapy for ROS1-positive metastatic NSCLC.

Review follows concerns over serious adverse events in ongoing clinical trials.

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.

FDA requested additional CMC information for the Multi-Dose Preservative-Free bottle.

New scheme supports European Commission priorities.

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.

First FDA-approved chemotherapy-free treatment option for first-line CLL patients.

Approval expands use and offers additional option for women with HR+, HER2- metastatic breast cancer.

Certified quality of analytical services for developers of biologics and biosimilars .

Filing based on Phase II study showing Blincyto provides meaningful therapeutic benefits in difficult-to-treat type of pediatric acute lymphoblastic leukemia.

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.

Top-line Phase Ib data in patients with CAD expected in mid-2016.

In advanced progressive, nonfunctional NET, Afinitor is the first approved treatment for patients with lung NET and the first oral therapy for GI NET.

This is the second FDA approval for Gazyva based on a positive Phase III study.

Application seeks to expand Avycaz label to include Phase III clinical data for the treatment of complicated intra-abdominal infections , in combination with metronidazole.

FDA decision anticipated in August 2016.

FDA provides GDUFA goal date of 28 March 28 2017

First-in-class therapy now approved for use in a broader range of women.

PKC412 (midostaurin) significantly improved overall survival of adult patients eligible to receive standard induction and consolidation chemotherapy.

The proposed rule would harmonize the requirements for prescription and nonprescription products.

Company due to supply its ANDA product during the second quarter of 2016.

Lilly plans to seek permission to appeal the ruling.

The company is reviewing the letter and will determine next steps.

First biotech company in Greater China region to receive European approval.

The CMA has fined a number of pharmaceutical companies for anti-competitive conduct and agreements in relation to the supply of paroxetine.

Sandoz's late-stage biosimilar pipeline gains momentum with sustained investment - five of 10 planned regulatory filings achieved.

With submission, Shire continues to strengthen its presence in Japan.

The first biosimilar monoclonal antibody reviewed, for all eligible indications.

Updated label provides new treatment option for patients with HIV-1 coinfection, advanced cirrhosis, and post-liver transplant HCV recurrence.

The indication sought for Apealea is treatment of epithelial ovarian cancer in combination with carboplatin.

MHRA grants UK lung cancer patients access to BMS's nivolumab.

Company plans to meet with FDA to determine appropriate path forward.

EMA approves Merck's GONAL-f prefilled pen 2.0.

Highlights include inspections, MRAs, harmonization efforts amd GMP/GDP guidance.

These guidelines primarily focus on recommendations for systems for manufactures of solid dosage forms.

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.

FDA grants Priority Review with target action date of 23 July 23 2016.

Resubmission includes positive data from OPUS-3, a Phase III efficacy and safety trial.

Boehringer Ingelheim and Eli Lilly and Company expect to receive a decision from the FDA within the standard review time frame.

The brodalumab BLA is supported by data from the three AMAGINE Phase III pivotal studies.

Opdivo + Yervoy Regimen now indicated for unresectable or metastatic melanoma patients, regardless of BRAF mutational status, based on accelerated approval.

Botox is the first and only FDA-approved neurotoxin treatment for both upper and lower limb spasticity.

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.

Baricitinib is for the treatment of moderate-to-severe rheumatoid arthritis.

Recommended for monotherapy or adjunctive therapy in the treatment of partial seizures.

Biogen will manufacture and commercialize Benepali in the EU.

Venetoclax, an investigational medicine, is a potential new way of treating the most common adult leukemia.

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.

Sarilumab is an investigational, human monoclonal antibody intended for the treatment of patients with active, moderate-to-severe rheumatoid arthritis

First non-alcohol formulation approved in the US.

Uptravi will be made available to patients in the US in early January 2016.

The increased surveillance resulted in the detection of hydrogen cyanide contamination in two shipments of drugs from Tianjin Tianyao Pharmaceuticals Co., Ltd.

Company makes significant investments in automation and training to enhance its Quality Systems

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.

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...

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...

Basaglar is the first FDA-approved follow-on insulin glargine treatment.

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.

The draft decision specifically affects adult patients with locally advanced or metastatic squamous non-small cell lung whose disease has progressed after prior chemotherapy.

The Guide covers GMP principles and active substances used as starting materials.

Kanuma is the first approved treatment in the US for patients suffering from LAL-D, a life-threatening and ultra-rare metabolic disorder.

The company intends to make faster-acting insulin aspart available in the prefilled delivery device FlexTouch.

Samsung Bioepis’ second immunology biosimilar approved, to be commercialized under partnership with Merck

Company eligible for 180-days marketing exclusivity on a first-to-file Para-IV ANDA.

Supported by Phase III studies in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis.

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...

Jardiance lowers the renal threshold for glucose, which leads to reduced renal reabsorption of filtered glucose and increased urinary glucose excretion.

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.

Company believes that an approval for the intended use of Epi proColon is warranted based on the data that has been submitted to date.

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.

Supported by Phase III studies in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis.

The company’s first branded drug approval outside of the US.

EMA ODD is an important regulatory milestone for avelumab in metastatic Merkel cell carcinoma (MCC).

Ninlaro provides a new option for patients living with multiple myeloma who have received at least one prior therapy.