Policy & Regulation News
Top Policy & Regulation News
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News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre...
Policy & Regulation news
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News Novartis agrees for copies to be made of cancer drug to reach poorer countries
Novartis signs agreement with MPP to have generics of it's leukemia drug made so that it can be more easily distributed to the world's poorer countries. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute. -
News New WHO health emergency guidelines expect full transparency from Big Pharma
The WHO are proposing a new set of pandemic guidelines to set out how future global health crises should be handled. -
News Biden's $2 billion Biotech Boost
President Biden issues executive order to bolster U.S. biomanufacturing sector. -
News US FDA grants priority review for Eisai and Biogen's Alzheimer's drug
Decision by US drug regulator on lecanemab expected by early next year -
News Panaxia's medical cannabis facility in Malta gains EU-GMP standard
This second facility gives the company a significant power multiplier for export capacity and geographical reach -
News CPHI Discover: Remote excipient audits are on the increase, but we must do more to develop novel excipients
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... -
News Pharma Explained: What is Quality Risk Management & cGMPs?
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... -
News Former FDA Commissioner lays out roadmap for building out excess capacity to deal with pandemic situations
Dr Scott Gottlieb shares insights into COVID-19 vaccine development, the upcoming US election and pharma pricing at the CPHI Festival of Pharma -
News Successful MHRA regulatory inspection for Scottish CMO Symbiosis
Inspection conducted remotely using video-conferencing and an online private document sharing platform. -
News Mylan and development partner win significant EPO ruling related to Copaxone
Decision clears legal pathway to expand access for patients living with multiple sclerosis in markets across Europe. -
News COVID-19 ushers in age of digital, flexible EU pharmaceutical regulation
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... -
News Europe's CHMP recommends suspension of medicines tested by Panexcell over flawed studies
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... -
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News FDA approves new Dupixent prefilled pen
The prefilled pen supports more convenient self-administration for patients with chronic type 2 inflammatory diseases. -
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News TraceLink announces results from FDA DSCSA Pilot Program
Key findings demonstrate the value of network solutions to secure and digitalize the pharmaceutical supply chain. -
News Chinese CDMOs legislating for the future
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 -
News EMA to only issue electronic medicines certificates during COVID-19 pandemic
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... -
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News Helsinn receives European approval of its IV formulation of Akynzeo
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. -
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News FDA approves Pharming's new facility for expanded Ruconest production
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... -
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News Potential first-in-class treatment reaches significant milestone
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. -
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News Novartis receives EC Approval for next-gen anti-VEGF treatment for wet AMD
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. -
News FDA approves only triple-combination tablet with Jardiance
Trijardy XR is a once-daily therapy combining three well-established treatments in one pill. -
News Lupin could face FDA regulatory action over Tarapur API facility
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. -
News 2019, the year that got serialization done!
The past 12 months have been busy as many companies fought to comply with serialization regulations. -
News Sartorius Stedim Biotech launches new Sartocheck 5 Plus filter tester
Highest level of data integrity as requested by regulatory authorities. -
News FDA approves first and only medicine in a new class of acute treatment for migraine
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. -
News EC approves its first plant-derived cannabis-based medicine
Epidyolex (cannabidiol) approved for the treatment of seizures in patients with two rare, severe forms of childhood-onset epilepsy. -
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News Taiwan's biggest CDMO secures FDA approval
Customers claim Bora's oral solid dosage Zhunan facility is in the top 5 external manufacturing facilities they’ve ever visited in the world. -
News FDA warns OTC drug manufacturer for drug manufacturing data integrity violations
Company provided FDA investigators with multiple documents that were falsified. -
News FDA approves Aptar's needle-free rescue treatment for severe hypoglycemia
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. -
News Legacy ramps up preparations for new Russian track and trace sterilisation regulations
Company to install new inspection cameras with higher resolution to ensure readability of more complex codes demanded by the Russian mandated crypto coding. -
News Particle Sciences expands controlled substance capabilities
Now authorized to test, develop and manufacture cannabis-derived pharmaceutical materials. -
News Brexit's trick or treat on patient safety
Despite a delayed Brexit, unpredictability adds further complications to the EU FMD regulation. -
News WuXi STA’s new drug product manufacturing facility passes first European MPA GMP Inspection
CDMO positioned to empower more customers to develop innovative drugs faster and more efficiently. -
News TraceLink submits an interoperable blockchain network solution for FDA DSCSA Pilot Project Program
Trace Histories is a purpose-built distributed ledger solution for ensuring patient safety by 2023 DSCSA deadline. -
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News Recipharm achieves new ISO 45001 certification to support sustainability efforts
ISO 45001 developed to improve employee safety, reduce workplace risk and create better working conditions globally. -
News Preservative-free multidose dispenser approved across Europe for glaucoma treatment
Aptar Pharma working closely with Santen Pharmaceutical to improve patient safety, achieve dosing accuracy and maintain product integrity. -
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News Sirio Pharma receives sports nutrition production licence approval
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’. -
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News All Recipharm facilities ready for EU serialisation, regardless of Brexit
The CDMO invested EUR 35 million into its operations and launched a 3-year programme to provide a compliant serialisation solution for its customers. -
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News Post-EU FMD deadline - 'business as usual'?
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. -
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News FDA approves first Nanobody-based medicine for adults with aTTP
Cablivi is the first US approval for Sanofi's new rare blood disorders franchise. -
News Brexit - the EU FMD's painful problem
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. -
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News FDA approves first generic Advair Diskus
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. -
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News UK and Russia sign MoU on regulatory co-operation on medicines
Medicines regulators of the UK and Russian set out key principles to support their collaboration on improving public health. -
News FDA approves first generic version of Sabril tablets
Approval of generic vigabatrin tablets granted to Teva Pharmaceuticals USA. -
News EU FMD - time is running out!
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. -
News Concept Life Sciences extends GLP accreditation to support regulatory studies
Accreditation ensures quality and integrity of non-clinical laboratory studies to support pharmaceutical and biotech industries. -
News Proprietary nasal delivery formulation of diazepam reaches NDA
The absolute bioavailability of the Valtoco intranasal formulation was 96% of intravenous diazepam in a Phase I cross-over trial. -
News Sandoz pulls the plug on US biosimilar rituximab
Company will focus on robust biosimilar portfolio for unmet access and sustainability needs. -
News Sanofi's formulation patents on multibillion-dollar Lantus are Invalidated by US PTE
Mylan achieves key milestone to provide US diabetes patients with more affordable generic version of Sanofi's Lantus insulin glargine vials. -
News Symbiosis secures FDA viral vector process approval
Strengthens the CDMO's position as a centre of excellence as part of the viral vector drug development supply chain. -
News New oral treatment for metastatic melanoma receives EU authorisation
Encorafenib in combination with binimetinib demonstrated 14.9 months median progression-free survival compared with vemurafenib monotherapy (7.3 months). -
News NMPA approves fruquintinib capsules for metastatic colorectal cancer
Fruquintinib - innovative medicine that has not previously been launched in China or internationally - provides a new therapeutic approach for metastatic colorectal cancer patients. -
News The 6-month FMD countdown - are you ready?
With only 6 months left in which to become EU FMD-compliant, how can companies make the best use of their now limited options? -
News Protecting the links between the UK and the EMA
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. -
News TraceLink announces Russia compliance solution
Company helps customers navigate and company with "one of the most complicated track and trace regulations in the world". -
News A new era for migraine patients
EU approves Novartis's Aimovig, a first-of-its-kind treatment specifically designed for migraine prevention. -
News Breast cancer device receives FDA approval
The first non-radioactive, dual-tracer for sentinel lymph node biopsy approved in the US. -
News Building contingency plans for an ambiguous post-Brexit market
One company's positive approach to Brexit preparations, despite the lack of definition. -
News Post-Brexit medicines - stuck in the UK?
The EMA needs to provide more action and guidance to help UK pharmaceutical manufacturers, says Thomas Beck, senior vice president, quality management, Recipharm. -
News Pharmacovigilance post-Brexit - simpler than previously thought?
To meet new PV regulations, the industry has to face a "multitude of unknowns and an ever-moving target". -
News FDA approves first smallpox drug
Action ensures that the US is prepared should smallpox be used as a bioweapon. -
News TraceLink unveils Product Information Manager for its digital information sharing platform
Product Information Manager addresses a broad range of use cases, beginning with saleable returns. -
News Recipharm launches standalone serialisation service
Company will be able to add 2D codes, human-readable text and tamper evidence to pre-packed medicines using existing equipment across its facilities. -
News Lilly wins patent case over Alimta
Ruling prevents Dr Reddy's Laboratories will from launching their alternative salt forms of pemetrexed until the patent expires. -
News First FDA approval of marijuana-based drug
Approval for seizures associated with Lennox-Gastaut Syndrome or Dravet Syndrome, two rare, severe childhood-onset epilepsies. -
News TraceLink customers receive EMVO approval for data submission to EU Hub
Company has developed a standard feature for its customers to execute the EMVO conformance testing successfully. -
News Serialisation — looking for value-added opportunities
Recipharm's Staffan Widengren, Director Corporate Projects, discusses why CMOs should be focusing on the value-added opportunities presented by serialisation. -
News Industry’s largest survey on serialization readiness throws up disparity
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. -
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News TraceLink unveils EU FMD Express
Purpose-built compliance solution for smaller pharmaceutical companies. -
News TraceLink's network approach gets pioneering German biotech EU FMD compliant
biosyn chooses a solution that ensures on-time compliance and delivers the required scalability. -
News Company goes all out to fully support clients
Gaining GLP/GMP accreditation to provide greater assurance of data integrity for clients looking to take their compounds to IND. -
News Expanded GXP compliance increases Concept's breadth of services
Successful MHRA inspection at Dundee site confirms GLP accreditation for in vitro safety studies and bioanalysis. -
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News 'Effective' hair loss treatment candidate advances to Phase IIa
German Medicines Agency sees potential in FOL-005 - a modified version of the endogenous protein, osteopontin - the green light for further studies. -
News Sanofi, DNDi seek EMA review for sleeping sickness treatment
Fexinidazole would be first all-oral treatment under investigation for both first and second stages of sleeping sickness, a fatal disease, endemic in Africa. -
News Companies warned for selling unapproved opioid cessation products using deceptive claims
The companies have 15 days to respond to the FDA and FTC. -
News Shire receives FDA approval for tech transfer of Cinryze
Commercial manufacturing of Cinryze drug product in Vienna to begin in the first quarter of 2018. -
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News Promacta receives FDA Breakthrough Therapy designation for first-line use in severe aplastic anemia
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%. -
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News Novartis Kisqali receives FDA Breakthrough Therapy designation
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... -
News Novartis' combination therapy Tafinlar + Mekinist granted FDA Priority Review
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. -
News ANVISA approves Biocon and Mylan's biosimilar Trastuzumab
Libbs will commercialize the product in Brazil under the brand name Zedora. -
News FDA approves first generic for Estrace Cream
Mylan now offers estradiol in four delivery methods. -
News FDA accepts NDA filing for Epidiolex in the treatment of Lennox-Gastaut syndrome and Dravet syndrome
The PDUFA goal date for completion of the FDA review of the Epidiolex NDA is 27 June 2018. -
News Novartis drug Tasigna approved by FDA
First and only CML therapy with Treatment-free Remission data in its label. -
News MAA submitted to EMA for patisiran for the treatment of hereditary ATTR amyloidosis
Sanofi and Alnylam's patisiran MAA to be reviewed under accelerated assessment. -
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News FDA approves the only OTC eye drop with low-dose Brimonidine to treat eye redness
Clinical studies showed 95% symptom improvement at one minute and reduced redness for up t 8 hours. -
News Allergan acknowledges Appeals Court decision for Combigan
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. -
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News Acerus receives Notice of Deficiency from Health Canada for Gynoflor
Health Canada requests additional technical information on Gynoflor to complete its assessment of the product. -
News FDA clears myPKFiT for ADVATE to help personalize care for hemophilia A
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. -
News New formulation of Oncaspar receives Marketing Authorization in Europe for patients with ALL
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. -
News Recipharm equips a further three facilities for US serialisation
CDMO's serialisation capabilities in place ahead of US deadline to avoid potential problems for our customers. -
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News FDA approves Zelboraf for Erdheim-Chester Disease
Zelboraf is the first FDA-approved treatment for Erdheim-Chester disease ECD, a rare blood disease. -
News RedHill Biopharma and IntelGenx submit NDA to FDA for Rizaport for migraines
Rizaport is a proprietary oral thin-film formulation of rizatriptan for the treatment of acute migraines. -
News FDA approves AstraZeneca's Calquence for adult patients with mantle cell lymphoma
Accelerated approval of Bruton tyrosine kinase inhibitor in MCL marks AstraZeneca's entry into the treatment of blood cancers. -
News Mylan wins UK court ruling related to Copaxone 40 mg/mL patent
Court finds all claims of Teva's patent relating to Copaxone invalid based on obviousness. -
News New European Council of regulatory professionals set to shape and support the profession
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 -
News FDA warns Pfizer company about cGMP violations associated with the manufacture of EpiPen
Warning letter cites Meridian Medical Technologies' failure to thoroughly investigate multiple serious component and product failures of EpiPen products. -
News Research reveals costly implementation is the biggest barrier to serialization compliance
The time it takes to develop a solution has been gravely underestimated by a large part of the industry. -
News Novo Nordisk settles US federal investigation of marketing practices
In connection with the $60 million settlement, the company has also resolved several private whistle-blower cases related to the government's investigation. -
News Life-extending pancreatic cancer medicine recommended by NICE in final guidance
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. -
News Takeda disappointed as NICE issue second negative draft decision for ixazomib
Company says it is determined to work collaboratively to find a solution. -
News Bayer submits BLA in the for BAY94-9027 – a long-acting factor VIII for the treatment of hemophilia A
Pivotal studies with BAY94-9027 showed that bleed protection was achieved with extended dosing intervals. -
News FDA approves Pfizer's Mylotarg for treatment of AML
Only approved antibody-drug conjugate for newly diagnosed and relapsed or refractory CD33-positive AML. -
News Lilly to file baricitinib resubmission to FDA before end of January 2018
Resubmission package will include new safety and efficacy data. -
News Novartis receives first ever FDA approval for a CAR-T cell therapy
Kymriah approvaed for children and young adults with B-cell ALL that is refractory or has relapsed at least twice. -
News FDA approves new antibacterial drug
First carbapenem-based combination product – combination of meropenem with a new class of beta-lactamase inhibitor. -
News Acordia's NDA generates Refusal to File letter from FDA
FDA cites two manufacturing concerns. -
News Biogen’s adalimumab biosimilar referencing Humira, is approved in the EU
Biogen becomes the first company with approved biosimilars for the three most prescribed anti-TNF biologic treatments in Europe. -
News Boehringer Ingelheim receives FDA approval for its Humira biosimilar
Cyltezo approved for the treatment of multiple chronic inflammatory diseases. -
News EC approves first oral short-course treatment for highly active relapsing multiple sclerosis
Mavenclad has shown sustained clinical efficacy for up to 4 years with a maximum of 20 days of oral treatment over 2 years. -
News FDA grants Priority Review to Genentech's emicizumab for Hemophilia A with inhibitors
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. -
News Hikma statement on generic Advair Diskus
Company been able to clarify and resolve a number of the questions raised by the FDA. -
News Shire submits lifitegrast MAA for treatment of dry eye disease in Europe
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. -
News FDA removes clinical hold on CEL-SCI’s Phase III head & neck cancer trial
The last FDA approved treatment for advanced primary head and neck cancer was over 50 years ago. -
News FDA approves liposome-encapsulated combination of daunorubicin-cytarabine for adults with AML
Vyxeos represents the first new chemotherapy advance in more than 40 years for these adults with AML. -
News NICE recommends Erbitux in combination with chemotherapy for the treatment of head and neck cancer
Decision secures access to Erbitux for new patients in England with oral cavity tumours. -
News Mylan receives tentative approval for "TLD" under PEPFAR
Mylan's TLD is the first fixed-dose combination of its kind to be offered to patients being treated for HIV/AIDS. -
News Insanitary conditions bring Isomeric Pharmacy Solutions to a halt
Federal judge enters consent decree against outsourcing facility Isomeric Pharmacy Solutions. -
News AbbVie's Mavyret receives FDA approval for the treatment of chronic hepatitis C
FDA approval is supported by an overall 98% cure rate in patients who received the recommended duration of treatment . -
News NICE approves Abraxane for pancreatic cancer
Life-extending pancreatic cancer medicine to be made available immediately on the NHS.
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