Policy & Regulation News

Decision by US drug regulator on lecanemab expected by early next year

This second facility gives the company a significant power multiplier for export capacity and geographical reach

Ahead of the session, Value Added Excipients to Unlock the Potential of APIs, at CPHI Discover on Thursday 18th May – global pharma’s largest ever virtual gathering – we spoke with one of the speakers, Dr Iain Moor...

Need clarity on determining your QA from your QbD and your cGMPs? You’re not alone! In our new Pharma Explained series from CPHI, we bring you clear cut definitions from industry experts on a myriad of Pharma Terms, delivered in bitesize video presenta...

Dr Scott Gottlieb shares insights into COVID-19 vaccine development, the upcoming US election and pharma pricing at the CPHI Festival of Pharma

Inspection conducted remotely using video-conferencing and an online private document sharing platform.

Decision clears legal pathway to expand access for patients living with multiple sclerosis in markets across Europe.

The pandemic that has swept over the world in 2020 has caused huge disruption to the European pharmaceutical industry's regulatory procedures and supply chain management. But the crisis has also provided a platform for a learning process for the sy...

The European Medicines Agency's human medicines committee (CHMP) has recommended the suspension of European marketing authorizations of generic medicines tested by Panexcell Clinical Laboratories at its site in Mumbai, India, citing irregularities in h...

The prefilled pen supports more convenient self-administration for patients with chronic type 2 inflammatory diseases.

Key findings demonstrate the value of network solutions to secure and digitalize the pharmaceutical supply chain.

The Chinese pharmaceutical CDMO sector is set for rapid expansion, thanks to major amendments to the country's Drug Administration Law that make outsourcing manufacturing easier

The European Medicines Agency (EMA) said Monday it will only issue electronically signed and authenticated certificates for human and veterinary medicines in place of printed ones so it can continue to provide the documents during the COVID-19 pandemic...

The new formulation offers patients in Europe an alternative route of administration of the only fixed antiemetic combination targeting two distinct CINV pathways in a single dose.

Netherlands-based specialty pharmaceutical company Pharming has received US Food and Drug Administration (FDA) approval for its new biologics facility in the Netherlands which it says will ensure sufficient manufacturing capacity for its acute heredita...

The US Food and Drug Administration (FDA) accepts for review Pfizer and Eli Lilly's Biologics License Application (BLA) for tanezumab — a non-opioid treatment for patients with chronic pain due to moderate-to-severe osteoarthritis.

Beovu is the only anti-VEGF treatment approved in Europe for wet AMD that offers the option to start eligible patients on 3-month dosing intervals immediately after the loading phase.

Trijardy XR is a once-daily therapy combining three well-established treatments in one pill.

The single-use, ready-to-use, one-step nasal delivery device can deliver a formulation in an emergency situation quickly and easily.

India’s Lupin Pharmaceuticals warned Monday it could face regulatory sanctions from the US Food and Drug Administration over its Tarapur active pharmaceutical ingredient (API) manufacturing facility.

The past 12 months have been busy as many companies fought to comply with serialization regulations.

Highest level of data integrity as requested by regulatory authorities.

The approval of Eli Lilly's Reyvow represents the first new class of acute migraine treatment approved by the FDA in more than two decades.

Provides migraine sufferers with a convenient, patient-friendly delivery approach.

Epidyolex (cannabidiol) approved for the treatment of seizures in patients with two rare, severe forms of childhood-onset epilepsy.

Customers claim Bora's oral solid dosage Zhunan facility is in the top 5 external manufacturing facilities they’ve ever visited in the world.

Company provided FDA investigators with multiple documents that were falsified.

Aptar’s nasal Unidose device - the result of a 10-year customer collaboration - marks the first FDA approval of a prescription drug using the company’s patented Unidose Powder System.

Company to install new inspection cameras with higher resolution to ensure readability of more complex codes demanded by the Russian mandated crypto coding.

Now authorized to test, develop and manufacture cannabis-derived pharmaceutical materials.

Despite a delayed Brexit, unpredictability adds further complications to the EU FMD regulation.

CDMO positioned to empower more customers to develop innovative drugs faster and more efficiently.

Trace Histories is a purpose-built distributed ledger solution for ensuring patient safety by 2023 DSCSA deadline.

ISO 45001 developed to improve employee safety, reduce workplace risk and create better working conditions globally.

Aptar Pharma working closely with Santen Pharmaceutical to improve patient safety, achieve dosing accuracy and maintain product integrity.

The approval enables Sirio to add special sports nutrition ingredients into products and covers six functional classes for ‘protein supplementary’, ‘speed & power’, ‘endurance’, ‘energy control’, ‘energy supplementary’, and ‘post-exercise recovery’.

The CDMO invested EUR 35 million into its operations and launched a 3-year programme to provide a compliant serialisation solution for its customers.

Partner connectivity will be an immediate and ongoing challenge beyond the deadline and several pharma companies are likely to break agreements with current suppliers through breach of contract clauses.

Cablivi is the first US approval for Sanofi's new rare blood disorders franchise.

Teething problems are no stranger to the implementation of new regulations, but with the EU FMD, Brexit came like a set of wisdom teeth – late, painful and problematic.

Mylan's Wixela Inhub is the first FDA-approved therapeutically equivalent generic of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for certain patients with asthma or COPD.

Medicines regulators of the UK and Russian set out key principles to support their collaboration on improving public health.

Approval of generic vigabatrin tablets granted to Teva Pharmaceuticals USA.

Companies that have left it too late to implement their own solution will have to rely on support from providers, whose resources are already in high demand as the deadline approaches.

Accreditation ensures quality and integrity of non-clinical laboratory studies to support pharmaceutical and biotech industries.

The absolute bioavailability of the Valtoco intranasal formulation was 96% of intravenous diazepam in a Phase I cross-over trial.

Company will focus on robust biosimilar portfolio for unmet access and sustainability needs.

Mylan achieves key milestone to provide US diabetes patients with more affordable generic version of Sanofi's Lantus insulin glargine vials.

Strengthens the CDMO's position as a centre of excellence as part of the viral vector drug development supply chain.

Encorafenib in combination with binimetinib demonstrated 14.9 months median progression-free survival compared with vemurafenib monotherapy (7.3 months).

Fruquintinib - innovative medicine that has not previously been launched in China or internationally - provides a new therapeutic approach for metastatic colorectal cancer patients.

With only 6 months left in which to become EU FMD-compliant, how can companies make the best use of their now limited options?

Now less than a year away from when the UK officially leaves the EU, the main goal remains the same - maintaining access to new drugs for patient health.

Company helps customers navigate and company with "one of the most complicated track and trace regulations in the world".

EU approves Novartis's Aimovig, a first-of-its-kind treatment specifically designed for migraine prevention.

The first non-radioactive, dual-tracer for sentinel lymph node biopsy approved in the US.

One company's positive approach to Brexit preparations, despite the lack of definition.

The EMA needs to provide more action and guidance to help UK pharmaceutical manufacturers, says Thomas Beck, senior vice president, quality management, Recipharm.

To meet new PV regulations, the industry has to face a "multitude of unknowns and an ever-moving target".

Action ensures that the US is prepared should smallpox be used as a bioweapon.

Product Information Manager addresses a broad range of use cases, beginning with saleable returns.

Company will be able to add 2D codes, human-readable text and tamper evidence to pre-packed medicines using existing equipment across its facilities.

Ruling prevents Dr Reddy's Laboratories will from launching their alternative salt forms of pemetrexed until the patent expires.

Approval for seizures associated with Lennox-Gastaut Syndrome or Dravet Syndrome, two rare, severe childhood-onset epilepsies.

Approval expands the regulatory acceptance of Aptar Pharma’s OSD as an approved delivery system for preservative-free eye care formulations.

Company has developed a standard feature for its customers to execute the EMVO conformance testing successfully.

Recipharm's Staffan Widengren, Director Corporate Projects, discusses why CMOs should be focusing on the value-added opportunities presented by serialisation.

Global Drug Supply, Safety and Traceability Report reveals disparity in industry’s readiness to comply with track and trace regulations in the US and EU.

Purpose-built compliance solution for smaller pharmaceutical companies.

biosyn chooses a solution that ensures on-time compliance and delivers the required scalability.

Gaining GLP/GMP accreditation to provide greater assurance of data integrity for clients looking to take their compounds to IND.

Successful MHRA inspection at Dundee site confirms GLP accreditation for in vitro safety studies and bioanalysis.

German Medicines Agency sees potential in FOL-005 - a modified version of the endogenous protein, osteopontin - the green light for further studies.

Fexinidazole would be first all-oral treatment under investigation for both first and second stages of sleeping sickness, a fatal disease, endemic in Africa.

The companies have 15 days to respond to the FDA and FTC.

Commercial manufacturing of Cinryze drug product in Vienna to begin in the first quarter of 2018.

Data supporting designation showed over half of treatment-naïve SAA patients achieved complete response with Promacta when given with standard immunosuppressive therapy, with overall response rate of 85%.

Designation based on Phase III MONALEESA-7 results demonstrating superior efficacy of Kisqali in combination with oral endocrine therapy compared to oral endocrine therapy in pre- or perimenopausal women who received no prior endocrine therapy for adva...

If approved, Tafinlar + Mekinist expected to be the first adjuvant targeted therapy combination to demonstrate a significant clinical benefit in patients with a BRAF V600 mutation.

Libbs will commercialize the product in Brazil under the brand name Zedora.

Mylan now offers estradiol in four delivery methods.

The PDUFA goal date for completion of the FDA review of the Epidiolex NDA is 27 June 2018.

First and only CML therapy with Treatment-free Remission data in its label.

Sanofi and Alnylam's patisiran MAA to be reviewed under accelerated assessment.

Clinical studies showed 95% symptom improvement at one minute and reduced redness for up t 8 hours.

Allergan plans to file petitions for rehearing of the appeals court decision and has asserted a new Orange Book patent against Sandoz's generic version of Combigan.

Health Canada requests additional technical information on Gynoflor to complete its assessment of the product.

First and only FDA-cleared PK dosing software to support healthcare professionals in creating personalized dosing regimens for patients 16 and older with hemophilia A.

Freeze-dried, or lyophilized, formulation aims to improve supply management by providing the same dosing regimen as liquid Oncaspar but with a three-times longer shelf life of up to 24 months.

CDMO's serialisation capabilities in place ahead of US deadline to avoid potential problems for our customers.

Zelboraf is the first FDA-approved treatment for Erdheim-Chester disease ECD, a rare blood disease.

Rizaport is a proprietary oral thin-film formulation of rizatriptan for the treatment of acute migraines.

Accelerated approval of Bruton tyrosine kinase inhibitor in MCL marks AstraZeneca's entry into the treatment of blood cancers.

Court finds all claims of Teva's patent relating to Copaxone invalid based on obviousness.

New European Council will support RAPS’ growing member base and volunteer network across Europe to ensure compliance with global regulations and to drive regulatory excellence

Warning letter cites Meridian Medical Technologies' failure to thoroughly investigate multiple serious component and product failures of EpiPen products.

The time it takes to develop a solution has been gravely underestimated by a large part of the industry.

In connection with the $60 million settlement, the company has also resolved several private whistle-blower cases related to the government's investigation.

The pivotal Phase III study demonstrated that treatment with Abraxane in combination with gemcitabine can offer patients a median overall survival improvement of 1.8 months.

Company says it is determined to work collaboratively to find a solution.

Pivotal studies with BAY94-9027 showed that bleed protection was achieved with extended dosing intervals.

Only approved antibody-drug conjugate for newly diagnosed and relapsed or refractory CD33-positive AML.

Resubmission package will include new safety and efficacy data.

Kymriah approvaed for children and young adults with B-cell ALL that is refractory or has relapsed at least twice.

First carbapenem-based combination product – combination of meropenem with a new class of beta-lactamase inhibitor.

FDA cites two manufacturing concerns.

Biogen becomes the first company with approved biosimilars for the three most prescribed anti-TNF biologic treatments in Europe.

Cyltezo approved for the treatment of multiple chronic inflammatory diseases.

Mavenclad has shown sustained clinical efficacy for up to 4 years with a maximum of 20 days of oral treatment over 2 years.

Application based on positive results of Phase III study in adults and adolescents with hemophilia A with inhibitors and interim Phase III results in children.

Company been able to clarify and resolve a number of the questions raised by the FDA.

Lifitegrast, if approved, would be the first and only new class treatment to address the signs and symptoms of dry eye disease in adults in Europe.

The last FDA approved treatment for advanced primary head and neck cancer was over 50 years ago.

Vyxeos represents the first new chemotherapy advance in more than 40 years for these adults with AML.

Decision secures access to Erbitux for new patients in England with oral cavity tumours.

Mylan's TLD is the first fixed-dose combination of its kind to be offered to patients being treated for HIV/AIDS.

Federal judge enters consent decree against outsourcing facility Isomeric Pharmacy Solutions.

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.