Policy & Regulation News

RHB-104 is a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation.

If the patent is ultimately upheld through all remaining challenges, Alimta would maintain US exclusivity until May 2022.

If approved, MYL-1401O has potential to be the first biosimilar trastuzumab in the US.

Company collaborating with all participants in the pharma supply chain to tackle to the epidemic of prescription drug abuse.

Application seeks to extend duration of use up to 4 years for Liletta.

BioNet's vaccine is the first recombinant monovalent Pertussis vaccine in the world to receive a MAA for booster indication in adolescents and adults.

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.

New FDA-approved indications for Adynovate provides more hemophilia A patients access to proven prophylaxis with a simple, twice-weekly dosing schedule.

Six patients have been identified with hepatotoxicity, including several cases of veno-occlusive disease, with four fatal events.

Spinraza improved motor function in SMA patients.

Payment resolves the outstanding civil penalty portion of the company's 2012 administrative settlement with this US DEA.

Oral Otezla receives positive NICE recommendation for adults with psoriatic arthritis.

European Commission decision confirms Metformin for treatment in type 2 diabetes patients with moderate renal impairment, which will lead to extended treatment access.

Extension is the result of the submission of additional data regarding the commercial manufacturing process of the biologic.

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.

Labeling revisions also include updates to corresponding warning and addition of clinical data on superior efficacy of Chantix compared with bupropion or nicotine patch.

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.

In its decision, the jury also concluded that Gilead “willfully” infringed upon the patent.

New once-a-day formulation indicated to improve blood sugar when used along with diet and exercise.

Lucentis the only treatment available for a wide range of CNV conditions.

Clinically proven and cost-effective solution for gastroesophageal reflux disease recently launched in China.

Pharma giant says it complied with established competition law.

The only oral T2D medicine to provide a life-saving cardiovascular benefit.

If approved by the FDA, avelumab could be the first treatment indicated for patients with metastatic Merkel cell carcinoma.

Opdivo is now the first and only PD-1 inhibitor approved for a hematologic malignancy in the European Union.

Pomalidomide available to people in England immediately via the Cancer Drugs Fund.

The type 2 diabetes treatment for adults will be delivered using SoloStar technology.

The XEN Glaucoma Treatment System reduces intraocular pressure in patients with refractory glaucoma.

Indication now includes use in children 6 months and older.

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.

For patients this could mean more are able to achieve a normal life expectancy, without compromising on their quality of life.

Trial results also provide a cost-saving argument for introducing Smartinhaler into routine practice.

Company prepares to start the production of sterile anti-infective injectable products at this site during 2018.

First treatment advance for secondary hyperparathyroidism in more than a decade.

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.

Treatment proven in a Phase III trial to significantly extend overall survival for patients with recurrent or metastatic squamous cell head and neck cancer.

Potential to be first submission of a proposed biosimilar trastuzumab in the US.

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.

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.

Is the first breast cancer treatment to be recommended by NICE in nearly a decade.

Trial showed LEE011 plus letrozole reduced the risk of progression or death by 44% over letrozole alone.

Europe to be a key market for the company's phage-based therapies to treat bacterial infections in patients with unmet medical needs.

If approved, avelumab, an investigational anti-PD-L1 IgG1, could be the first treatment indicated for patients with metastatic Merkel cell carcinoma.

Deficiencies identified during a routine good manufacturing practice inspection of the Sanofi Le Trait facility in France where sarilumab is filled and finished.

Provides pan-European availability of widely used and much needed oral liquid version clobazam tablets.

Approval is for first-line treatment of patients whose tumours have high PD-L1 expression with no EGFR or ALK genomic tumour aberrations.

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.

First and only anti-PDL1 cancer immunotherapy approved by the FDA for metastatic non-small cell lung cancer.

Includes Merck’s type 2 diabetes treatment portfolio, in patients with renal impairment.

Marketing authorization given for the treatment of moderate to severe fullness under the chin.

TNT009 is currently in clinical development for the treatment of autoimmune hemolytic anemia, including Cold Agglutinin Disease (CAD), a form of autoimmune hemolytic anemia.

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.

Application seeks to expand Avycaz label to include Phase III clinical data for the treatment of complicated urinary tract infections.

The new formulation will be offered in 4,000 lipase units capsule.

Shire pleased with the decision and will continue to vigorously defend its patents.

The introduction of a single vial presentation was part of commitments required by the FDA when it approved Egrifta (Tesamorelin for Injection).

Submission of Marketing Authorization Application to the EMA planned in the coming weeks.

Amjevita is the first adalimumab biosimilar approved by the FDA and has been approved for the treatment of seven inflammatory diseases.

Ilaris is the first and only US FDA-approved biologic treatment for patients with TRAPS, HIDS/MKD and FMF disease.

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.

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.

Shire to consider appeal.

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.

Patent covers East Indian sandalwood oil-containing compositions that can be used to treat a variety of cancers.

Is the first registration Dechra has achieved through Putney's development pipeline since it acquired the US-based business

Designation also includes the associated interstitial lung disease.

AZD3293 is an investigational treatment for early Alzheimer's disease

Products now approved in seven countries.

EMA's CHMP to begin centralized review procedure.

Agency request additional information primarily related to manufacturing.

Decision taken after company refuses to allow FDA facility inspection.

Marketing Authorization Application to the EMA currently under review.

New treatment option for patients with with disease progression on or after platinum-containing chemotherapy.

Natco receives approval for generic Tamiflu.

Another Rx-to-OTC Switch from GSK Consumer Healthcare to help allergy sufferers find more complete relief.

LEE001 potential first-line treatment for HR+/HER2- advanced breast cancer.

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.

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.

Designation is for an investigational treatment of adults who have nonalcoholic steatohepatitis (NASH) with liver fibrosis.

Adlyxin is approved as Lyxumia in more than 60 countries.

FDA reports deficiencies in manufacturing process and controls identified during a pre-NDA approval inspection of the Ocular Therapeutix manufacturing facility.

Significant step towards bringing the only licensed prescription medication for IBS-D to patients in 28 countries of the EU.

Morphochem’s novel intravenous antibacterial to treat C. difficile infections.

Based on Phase III FRAME Study in postmenopausal women with osteoporosis.

Expanded indication now includes treatment-naïve adults.

The approval of SB5 could make Biogen the first company to commercialize three anti-TNF biosimilar therapies in Europe.

A first of its kind approach to increasing tear production in patients suffering from dry eye disease.

Committee votes unanimously in favor of the Sandoz proposed biosimilar etanercept for all approved indications of the reference product.

Prevnar 13 is the only pneumococcal vaccine approved in the US for patients 6 weeks through adulthood.

Xiidra is the only treatment Indicated for the signs and symptoms of dry eye disease.

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.

Amgen's Repatha (evolocumab) Pushtronex system (on-body infusor with prefilled cartridge) provides a new, monthly single-dose administration option.

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.

Approval makes Xolair the only biologic for children ages six and up with uncontrolled allergic asthma.

First therapy indicated in the EU for use in patients aged one year and above with Short Bowel Syndrome, a rare gastrointestinal condition.

Head-to-head Phase III trial demonstrated superiority of Kyprolis and dexamethasone over Velcade and dexamethasone in patients with relapsed multiple myeloma.

This significant site addition to Siegfried’s production network strengthens the company’s long-term competitiveness.

Endocrinologic and Metabolic Drugs Advisory Committee votes in favour of cardiovascular mortality benefit for JARDIANCE for adults with type 2 diabetes.

This milestone marks the sixth Breakthrough Therapy Designation for Opdivo.

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.

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...

Shortcomings include insufficient measures to reduce the risk of cross-contamination, as well as quality assurance.

First drug to use Catalent’s proprietary OptiShell capsule technology to achieve extended release profile.

Move approves the use of contract manufacturing organisations.

This represents one of the fastest ever approvals by NICE – UK patients will be the first to benefit across Europe.

“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.”

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.

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.

Vaxchora is the only approved vaccine in the US for protection against cholera.

The FDA Prescription Drug User Fee Act target action date is expected to occur in early 2017.

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.

New formulation of medicines that helps lower blood sugar in type 2 diabetes can be taken once a day.

Biogen to manufacture and commercialize Flixabi, the company’s second anti-TNF biosimilar therapy in the EU.

Product launches estimated to begin in the fourth quarter of 2016 or the first quarter of 2017.