Pharmaceutical Technology

SEPTEMBER 7, 2022

The rising incidence of long-standing diseases such as hypertension, diabetes, cardiovascular diseases, and cancer requires prolonged medication and, thus, drives the growth and need for retail pharmacies in the market. The list includes companies offering various products and services, including but not limited to: · Over-the-counter drugs.

Pharmacy 147

Pharmacy Containment Generic Drugs Production 147

FDA Law Blog

MARCH 5, 2024

First, AstraZeneca alleged that CMS improperly defined a “qualifying single source drug” to include all dosage forms and strengths of the drug marketed by the manufacturer with the same active moiety or ingredient—even if those different forms and strengths were approved under different NDAs. Opinion at 17.

Generic Drugs 62

Generic Drugs Marketing Drugs Production 62

pharmaphorum

MARCH 5, 2021

Copaxone (glatiramer) was once a mainstay of Teva’s portfolio with blockbuster sales that the Israel-based pharma fought hard to protect, including releasing a long-acting version to counter cheaper copycat drugs. In the end it wasn’t enough and sales last year were $213 million, a fraction of the $4.3

Drugs 98

Drugs Sales Pharma Companies Generic Drugs 98

pharmaphorum

NOVEMBER 2, 2020

Mylan’s $12 billion takeover of Pfizer’s Upjohn unit has been cleared by the US authorities, but on the condition that the two companies divest various generic drug products. Once formed, Viatris will be a generics behemoth with annual sales of around $19 to $20 billion and operations in 165 markets around the word.

Generic Drugs 52

Generic Drugs Contract Manufacturing Production Manufacturing 52

Camargo

NOVEMBER 11, 2020

When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product.

Development 242

Development Bioequivalency Generic Drugs Production 242

pharmaphorum

FEBRUARY 2, 2022

Pharming has taken a step closer to getting a second product to market, after its rare disease therapy leniolisib met its objectives in a pivotal trial, setting up regulatory filings in the coming months. For comparison, Takeda reported sales of around $415 million in the first six months of the 2021-22 fiscal year.

Trials 52

Trials Drugs Sales Generic Drugs 52

pharmaphorum

MARCH 16, 2022

Viatris’ generic of Symbicort (budesonide and formoterol fumarate dihydrate) – developed by Viatris in collaboration with 3M spin-off company Kindeva Drug Delivery and called Breyna – has been cleared for the same indications as the brand, namely maintenance treatment for asthma and chronic obstructive pulmonary disease (COPD).

FDA Approval 59

FDA Approval Generic Drugs Marketing Drug Delivery 59

pharmaphorum

AUGUST 20, 2020

Shares in Teva were down sharply this week after the US Department of Justice filed a complaint that the company paid illegal kickbacks to patient groups to boost sales of its multiple sclerosis drug Copaxone (glatiramer). The allegation is that Teva’s subsidiaries Teva Pharmaceuticals USA Inc. and Teva Neuroscience Inc.

Generic Drugs 112

Generic Drugs Sales Pharmacy Pharma Companies 112

pharmaphorum

JUNE 3, 2021

The FDA approval of Alkermes’ new antipsychotic drug Lybalvi couldn’t have gone any better for the company, but it could still face a big challenge positioning the new drug in the highly genericised market. It has however been contraindicated in people taking opioids.

FDA Approval 52

FDA Approval Marketing Branding Generic Drugs 52

pharmaphorum

JULY 29, 2021

The UK has levied another big fine for anticompetitive activity in the pharma market in a fortnight, with Advanz Pharma and former owners on the hook for more than £100 million ($140 million) after increasing the price of a thyroid disease drug by 1,110% over an eight-year period. ” Advanz itself was directly fined £40.9

Drugs 98

Drugs Marketing Generic Drugs Hormones 98

Camargo

DECEMBER 9, 2020

Evergreening Orphan Drugs May Be Over. The Orphan Drug Act of 1983 provides market exclusivity for drugs intended to treat conditions affecting fewer than 200,000 patients in the US. Unapproved Drug Initiative Ends. In November, the FDA ended its Unapproved Drug Initiative.

Development 140

Development Production Drugs FDA Approval 140

pharmaphorum

JULY 29, 2021

Now, interchangeable status means that is considered to have no clinically meaningful difference to Lantus in safety, purity or potency, so can be substituted for the reference drug without any prescriber intervention – just like a regular generic drug can in many US states.

Insulin 98

Insulin Drugs Production Generic Drugs 98

Pharmaceutical Technology

OCTOBER 5, 2008

In addition, one very notable deal with India hints that Asia’s emerging market is also having a growing influence on what is happening in Japan. ’ Generic drug renaissance Shionogi’s acquisition of Sciele was partly due to the US business experience of Shionogi’s chief executive, Isao Teshirogi.

Generic Drugs 130

Generic Drugs Marketing Branding Drugs 130

pharmaphorum

JANUARY 25, 2022

.” The online pharmacy launch comes a few weeks after Cuban set up a pharmacy benefit manager (PBM) operation – the Mark Cuban Cost Plus Drug Company (MCCPDC) – promising to cut out the middleman in the medicines supply chain so it can eliminate markups on generic drugs and pass savings on to its customers.

Medicine 52

Medicine Pharmacy Generic Drugs Drugs 52

The Pharma Data

DECEMBER 28, 2020

This further highlights Amphastar’s considerable abilities to bring complex generic drugs to the market, and more specifically, our strong peptide capabilities.” sales for Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, 1 mg, were approximately $144 million, and the overall U.S. Company Information.

Bioequivalency 52

Bioequivalency Production Sales Marketing 52

FDA Law Blog

AUGUST 29, 2024

After all, as we have written before in other contexts ( i.e. , the BLOCKING Act), “[I]f you limit a generic drug manufacturer’s ability to settle cases, that manufacturer does not settle fewer cases, it submits fewer Paragraph IV ANDAs. And fewer ANDAs means less, not more, generic drug competition.”

Production 57

Production Licensing Licensing Generic Drugs 57

Creogenic Pharma

APRIL 15, 2023

The Indian pharmaceutical market reached a value of around $27 billion by the end of 2017 and is predicted to experience a CAGR of over 5% for the next five years, reaching over $60 billion by 2022. India is a major player in the global pharmaceutical industry, accounting for almost 20% of the export volume of generic drugs worldwide.

Pharma Companies 40

Pharma Companies Production Manufacturing Generic Drugs 40

FDA Law Blog

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers.

Drugs 44

Drugs Manufacturing Generic Drugs Production 44

The Pharma Data

MARCH 9, 2021

This first-to-market generic version of AZOPT ® (brinzolamide ophthalmic suspension) 1% in the U.S. provides patients with another important treatment option,” said Christine Baeder, SVP, Chief Operating Officer US Generics, Teva USA. Currently, one in ten generic prescriptions dispensed in the U.S.

Doctor 52

Doctor Doctors Production Generic Drugs 52

FDA Law Blog

JUNE 2, 2022

Since 1984, generic drugs have been approved under ANDAs pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (FDCA); before 1984, no formal mechanism for an ANDA existed so FDA used sections 505(b) and 505(c) to approve follow-on drugs based on the Agency’s previous findings of safety and efficacy.

Drugs 52

Drugs Production Generic Drugs Cosmetics 52

The Pharma Data

DECEMBER 4, 2021

The launch of our first-to-market authorized generic version of Epiduo® Forte Gel in the U.S. provides patients with another important treatment option,” said Christine Baeder, SVP, Chief Operating Officer US Generics, Teva USA. Currently, 1 in 11 generic prescriptions dispensed in the U.S.

Doctor 52

Doctor Doctors Medicine Production 52

XTalks

FEBRUARY 5, 2024

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.

FDA Approval 82

FDA Approval Drugs Sales Development 82

FDA Law Blog

SEPTEMBER 6, 2021

Typically, generic sponsors carve out a patent-protected indication or patient population, but technically, any method of use can be carved out as long as FDA determines that the product can still be used safely and effectively without the patent-protected information. The catch is, as we have learned from the GSK v.

Generic Drugs 52

Generic Drugs Production Drugs Marketing 52

The Pharma Data

MARCH 7, 2022

“The launch of our first generic version of Revlimid® in the U.S. This product adds to our broad generic portfolio of oncology treatments, which accounts for 73% of the essential medicines in this category, as defined by the World Health Organization.”. Currently, 1 in 12 generic prescriptions dispensed in the U.S.

Medicine 52

Medicine Production Generic Drugs FDA Approval 52

XTalks

FEBRUARY 8, 2021

In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “generic” drugs of the biopharma world.

Production 57

Production Insulin Branding Generic Drugs 57

XTalks

AUGUST 2, 2023

Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations. is a global pharmaceutical company, working across both developed and emerging markets. billion in pharmaceutical sales from 2021. billion, a 42.74

Sales 91

Sales Manufacturing FDA Approval Life Science 91

Pharmaceutical Technology

JULY 15, 2022

Nothing epitomises market failures more than the cost of insulin,” Newsom said in a video posted on Twitter. CivicaRx is a non-profit generic drug company producing affordable insulin biosimilars in collaboration with the Juvenile Diabetes Research Foundation (JDRF). In-house manufacturing the norm.

Insulin 328

Insulin Manufacturing Contract Manufacturing Production 328

The Pharma Data

JANUARY 17, 2021

The Company will continue to leverage its scientific expertise and operations in Europe and North America for product development and optimization while it plans to add significant commercial experience in the fields of manufacturing, distribution, marketing and sales. Drug Formulations and Delivery.

Production 40

Production Development Drug Delivery Drugs 40

XTalks

FEBRUARY 5, 2024

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.

FDA Approval 52

FDA Approval Drugs Sales Development 52

FDA Law Blog

JANUARY 11, 2022

Teva , the generic industry has been waiting with bated breath to see whether the section viii carve-out (and thus skinny-labeled generic drugs) will survive. Hikma , the generic industry can have some hope. Koblitz — Since the August 2021 decision in GSK v. The Court again made sure to emphasize language from GSK v.

FDA Approval 52

FDA Approval Production Branding Drugs 52

FDA Law Blog

JANUARY 11, 2022

Teva , the generic industry has been waiting with bated breath to see whether the section viii carve-out (and thus skinny-labeled generic drugs) will survive. Hikma , the generic industry can have some hope. Koblitz — Since the August 2021 decision in GSK v. The Court again made sure to emphasize language from GSK v.

FDA Approval 52

FDA Approval Production Branding Drugs 52

Pharmaceutical Technology

JULY 10, 2008

As the blockbuster drugs of the 90s that earned the industry billions reach their patent shelf lives, pharmaceutical companies require new medicines to sustain an estimated $157bn worth of sales. Even so, current figures show firms’ biggest portion of spend is still on marketing and administration at 33.1%,

Medicine 130

Medicine Clinical Trials Clinical Trials Development 130

Pharma in Brief

FEBRUARY 8, 2024

The Notice advises that if an innovative drug is categorized as “Dormant” in Health Canada’s Drug Product Database, then a generic manufacturer can compare its drug against an alternate CRP, which could include another generic drug, when filing an Abbreviated New Drug Submission ( ANDS ).

Production 52

Production Generic Drugs Bioequivalency Drugs 52

The Pharma Data

MAY 6, 2021

Moderna lifts COVID-19 vaccine sales forecast to $19.2 Taking double Covid-19 hits, Merck writes off $170M for scrapped drug, highlights $600M in missed sales ( Endpoints ). Biogen’s Alzheimer’s drug may only be cost effective at $2,500 a year ( STAT ). billion ( Reuters ) ( WSJ ).

Sales 52

Sales Vaccination Vaccine Gene Therapy 52

pharmaphorum

NOVEMBER 26, 2020

For Pawlu, COVID-19 has highlighted how we transform the way the industry works – from manufacturing and supply chains, to sales and detailing – in a way that ensures everyone can access the high quality, affordable medicines they need to live happier, healthier lives. About the interviewee.

Production 111

Production Manufacturing Sales Marketing 111

Pharma in Brief

JUNE 21, 2020

They include: (1) new factors for assessing excessive pricing, (2) new powers to collect information regarding these factors, (3) new obligations to report indirect price adjustments, (4) risk-based reporting obligations for OTC and generic drugs, and (5) a revised list of international price comparator countries (the PMPRB11 ).

Medicine 40

Medicine Regulation Sales Generic Drugs 40

The Pharma Data

JANUARY 27, 2021

The addition of in-house, scalable commercial drug manufacturing capability is expected to add significant value and optionality to XPhyto’s drug formulation business. In 2020, XPhyto reported significant advancements in four drug formulation development programs.

Drugs 52

Drugs Manufacturing Drug Delivery Production 52