Policy & Regulation News

FDA approval is supported by an overall 98% cure rate in patients who received the recommended duration of treatment .

Life-extending pancreatic cancer medicine to be made available immediately on the NHS.

Designation given for initial treatment of people with ALK-positive lung cancer.

Approval based on CheckMate -142, in which Opdivo demonstrated an objective response rate of 28% among patients who received prior treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

Results from the Phase III study included in the sBLA submission showed that treatment with Prolia for 12 months led to statistically significant greater gains in BMD at the lumbar spine and total hip compared to risedronate.

New approval for treatment of active psoriatic arthritis (PsA).

40% of industry professionals admit they are not clear about the global requirements for serialization.

The biosimilar's list price will represent a 35% discount to the current list price of Remicade.

If approved, Rydapt would represent the first targeted treatment for newly diagnosed FLT3-mutated AML in the EU.

The approval marks the first subcutaneous self-injection treatment option for patients with systemic lupus erythematosus.

Nerlynx is the first extended adjuvant therapy for patients with HER2-positive breast cancer.

Company expects to launch by the end of the year.

Vote marks first proposed biosimilar trastuzumab to be recommended by the committee.

A BLA for this indication is under FDA priority review; if approved, CTL019 could become first CAR-T cell therapy available.

Anticipated Prescription Drug User Fee Act (PDUFA) action date for the sNDA is March 2018 .

Cialis exclusivity is now expected to end at the earliest on 27 September 2018.

Blincyto is the first and only Bispecific T cell Engager (BiTE) immunotherapy to demonstrate superior overall survival versus standard of care chemotherapy.

Patients in Scotland will now join those in England and Wales and be able to benefit from this potentially life-extending immunotherapy on the NHS.

Orencia now approved in three autoimmune diseases.

Actavis's products directly infringe Lilly's vitamin regimen patents in the UK, France, Italy and Spain.

ALM201 is a therapeutic peptide developed to mimic some of the properties of the naturally occurring protein FKBPL.

Company has immediately initiated commercialization activities.

Label update includes 52 week data from CLEAR study demonstrating long-term superiority of Cosentyx versus Stelara in psoriasis.

Pharma clients now have direct and immediate access to a fully compliant safety database without needing to invest in their own system or use an interim solution to ensure compliance.

First shipment of BIOCAD’s Acellbia to India is scheduled for September 2017.

In clinical studies, baricitinib has demonstrated significant improvement in the signs and symptoms of RA compared to standard-of-care therapies.

First-and-only fully human monoclonal anti-epidermal growth factor receptor antibody approved by the FDA for this patient population.

In ALK-positive advanced NSCLC patients, Zykadia demonstrated superior median progression-free survival compared with SOC chemotherapy with maintenance.

The CDMO is now approved to manufacture medicinal products for the US, Europe and Japan.

Resourcing the deployment of serialization systems and processes also cited as a significant barrier to compliance with European FMD,

Cladribine Tablets is the first and only investigational medicinal product to have shown a sustained 4 years of disease control with a maximum of 20 days of oral treatment over 2 years in clinical trials.

New indication supported by results of Phase III PALOMA-3 Trial of Ibrance in combination with fulvestrant.

If approved, Imraldi will be the third anti-TNF biosimilar in Biogen’s portfolio in Europe.

Mydayis demonstrated improvements lasting up to 16 hours post-dose, beginning at 2 or 4 hours post-administration, compared with placebo, in total score on a skill-adjusted math test that measures attention in ADHD.

AMG 334 (erenumab) is the first anti-CGRP monoclonal antibody developed for migraine prevention to receive EMA regulatory filing acceptance.

Xgeva is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumours and is the number one prescribed agent by oncologists for this indication in the US.

Sandoz now has four biosimilars approved in Europe - more than any other company.

Pfizer says shortages caused by manufacturing, distribution and third party delays.

Sandoz believes its combination product will offer asthma and COPD patients same safety and efficacy as reference medicine.

Currently there are no approved topical NSAIDs indicated for the treatment of migraine.

Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatit.is C

The Committee will review analytical, pharmacokinetic and clinical data from studies involving ABP 215, including results from a Phase III study in patients with NSCLC.

Robust data from Phase III studies demonstrated positive impact on motor milestone achievement; increased survival in infants with SMA.

NICE has recommended immunotherapy drug nivolumab for the treatment of adult patients with classical Hodgkin lymphoma.

Biosimilar infliximab alone could potentially save the NHS £89 million.

Recall due to out of sequence tablets and missing expiry/lot information.

Application is based on results from the Phase I/II CheckMate -040 trial.

Industry and regulators combine to run afternoon congress on the implications of regulatory changes.

Kevzara is now available to US patients.

Sixth FDA approval for Actemra since its US launch in 2010,

Proposal extends application to the treatment of children and adolescents with chronic phase Philadelphia-chromosome positive chronic myelogenous leukemia and to the powder for oral suspension.

Certification covers the manufacture and packaging of hard and soft gel capsules, liquids for external use, semi-solids such as ointments and film coated tablets.

The e-Lockout device being the first and only fully integrated electronic nasal drug delivery device to be approved by a US or European regulatory authority.

Many companies currently unprepared because they lack the internal resources to devote to serialization.

Company believes low likelihood of approval this year.

FDA approves Keytruda as first-line combination therapy with pemetrexed and carboplatin for patients with metastatic nonsquamous non-small cell lung cancer (NSCLC) irrespective of PD-L1 expression.

European Commission approves Keytruda for patients with relapsed or refractory classical Hodgkin lymphoma who failed ASCT and BV or who are transplant-ineligible and have failed BV.

Imfinzi is the cornerstone in an extensive immuno-oncology program across multiple cancer types and stages of disease.

One of the first companies to offer a generic version of Vytorin.

Alunbrig approved for ALK+ metastatic non-small Cell lung cancer patients who have progressed on or are intolerant to crizotinib.

Daklinza and Sunvepra combination approved for genotype 1b, the most common chronic hepatitis C (HCV) genotype in China; combination has a 91-99% cure rate.

Natpar is the first and only licensed recombinant human parathyroid hormone therapy for chronic hypoparathyroidism.

Monthly dosing schedule now approved in both US and EU.

Company has invested €300,000 into the project, which is part of a wider €40 million investment into new serialisation technology and processes to comply with the European Falsified Medicines Directive.

Company receives positive CHMP opinions for biosimilars rituximab and etanercept to treat immunological diseases. Biosimilar rituximab also recommended to treat blood cancers.

First and only medicine FDA-approved to treat all forms of diabetic retinopathy.

Additional clinical data are needed to determine the most appropriate doses.

First HCV direct-acting antivirals approved for use in adolescents.

CRL relates to Merck's sNDA for Januvia, Janumet and Janumet XR.

Agreement terms are "favourable for both parties".

Applications include data from the largest international trial conducted in multiple myeloma.

Company's CAPA addresses the three Form 483 observations.

New indication of Tafinlar and Mekinist in advanced NSCLC provides only therapy approved in the EU for BRAF V600-positive NSCLC.

An important new treatment option for people with relapsing forms of multiple sclerosis demonstrating superior efficacy on the three major markers of disease activity compared with Rebif.

US commercial launch planned for late April.

First targeted biologic therapy for adults with moderate-to-severe atopic dermatitis.

Trumenba has been studied in a global clinical development program evaluating the vaccine in adolescents and adults.

Opdivo already approved by the EC for six indications in four distinct tumour types.

First NCE approved for PD patients with motor fluctuations in the US in more than a decade .

TLE400 is a fixed-combination containing Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 400 mg/300 mg/300 mg.

Kisqali plus letrozole showed treatment benefit across all patient subgroups regardless of disease burden or tumour location.

Cinryze is the first and only Hereditary angioedema treatment approved for routine prevention in paediatrics.

Only anti-PD-1 therapy approved for the treatment of patients with difficult-to-treat cHL regardless of prior stem cell transplantation or use of brentuximab vedotin

Dietary supplement products "misbranded" and unapproved new drugs being marketed with drug claims despite not being approved for any use.

Settlement provides Mylan with global licenses for its trastuzumab product.

BI 836858 was previously granted orphan drug designation for the treatment of patients with AML.

Application seeks to expand Vraylar label to include Phase III clinical data for the maintenance treatment of schizophrenia.

Represents Biocad's third authorized medicine for the treatment of relapsing-remitting multiple sclerosis.

More patients now able to receive a standard-of-care treatment with Erbitux plus Folfiri or Folfox.

Second Biologics License Application accepted by the FDA for avelumab.

If approved, Natpar would be the first licensed recombinant parathyroid hormone in Europe for the management of chronic hypoparathyroidism, the only endocrine-deficiency disorder with no hormone treatment.

Steroid-free Spiriva Respimat now approved as asthma treatment for age 6 and older.

The proposed biosimilar to Neulasta is used to reduce the duration of neutropenia and the incidence of fever associated with neutropenia in adult patients treated with chemotherapy in certain types of cancer.

More than 50% of patients in three clinical studies who used Siliq achieved total skin clearance within a year.

Baricitinib, marketed as Olumiant, is the first JAK inhibitor approved to treat RA in the EU.

In the first video in our new series; Pharma Explained, Francess Zipp of Lachman Consultants explains why Good Manufacturing Practices (GMPs) are important and how a strong quality risk management system can ensure adherence to the GMPs.

Praluent continues to be available to patients in the US.

Trulicity is a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist injectable prescription medicine.

Intravenous administration puts delivery in hands of healthcare provider.

Landmark Repatha cardiovascular outcomes study meets primary and key secondary endpoint.

Keytruda also receives Breakthrough Therapy Designation for second-line treatment.

Opdivo has now been approved in six tumour types in just over 2 years.

First anti-PD-1 therapy approved in Europe for previously untreated patients with metastatic NSCLC.

Patent found to be invalid.

Xyzal is an oral antihistamine with a proven 24-hour effect.

Decision marks the third TSC-related indication for Votubia in the EU.

Patents in question invalidated based on obviousness.

New clinical data for Avycaz demonstrates efficacy in cUTI patients including those with infections due to resistant Gram-negative pathogens.

First treatment approved in 5 years for adolescents aged 13-17 years with schizophrenia.

Amgen receives positive CHMP opinion for biosimilar adalimumab.

New dosage strength expected to be available in first quarter of 2017.

VR647 is a drug/device combination, using the AKITA JET smart nebuliser, for the delivery of nebulised budesonide.

No admission of wrongdoing, No monetary payment by Endo.

Topline results from the Phase II trial are expected by year-end 2017.

Sofosbuvir/Velpatasvir/Voxilaprevir cranted an accelerated assessment by the EMA.

Once-daily treatment reduces persistent facial erythema associated with rosacea through 12 hours.

Suliqua will be delivered in two pre-filled SoloSTAR pens, providing different dosing options that may help answer individual market and patient insulin needs.

No concerns raised by FDA related to the rolapitant IV efficacy or safety profile and additional clinical studies are not required.

Novo Nordisk to launch Fiasp in first half of 2017.

Product receives designations for both the BV treatment and prevention indications.