Pharmaceutical Technology

JULY 28, 2022

The wAMD and GA markets are anticipated to reach values of $18.8bn and $4.0bn, respectively, in 2031 in the 7MM. The wAMD and GA markets are anticipated to reach values of $18.8bn and $4.0bn, respectively, in 2031 in the 7MM. The therapy received FDA approval in October last year.

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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. The post After FDA approval, Alkermes plans soft launch for antipsychotic Lybalvi appeared first on.

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pharmaphorum

JANUARY 21, 2021

Bayer and Merck & Co’s heart failure drug vericiguat has been approved by the FDA under the brand name Verquvo, in an increasingly competitive market. But the drug is entering an increasingly competitive market, where Novartis and AstraZeneca are vying for supremacy.

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XTalks

APRIL 11, 2024

After backing from the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) last month, Johnson and Johnson (J&J) and Bristol Myers Squibb (BMS) scored FDA approvals for the use of their B-cell maturation antigen (BCMA)-targeting CAR T-cell therapies as earlier line treatment options for multiple myeloma.

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XTalks

AUGUST 2, 2022

The US Food and Drug Administration (FDA) has granted approval to Azurity Pharmaceuticals’ liquid version of its epilepsy drug zonisamide (100 mg/5 mL; brand name Zonisade) as an adjunct therapy for the treatment of partial seizures in adults and pediatric patients 16 years of age and older with epilepsy.

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FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target.

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Pharmaceutical Technology

MARCH 24, 2023

Amgen’s (US) Amjevita (adalimumab) is the first Humira biosimilar, launched in February 2023, and seven other FDA-approved biosimilars are expected to arrive on the US market later this year. In addition, two more Humira biosimilars are currently under FDA review and both are anticipated to launch in 2023.

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XTalks

AUGUST 31, 2023

As Takeda’s blockbuster attention-deficit/hyperactivity (ADHD) drug Vyvanse (lisdexamfetamine dimesylate) reached its patent cliff this month after enjoying 16 years on the market, the US Food and Drug Administration (FDA) gave approval to a slew of generics to coincide with the end of its patent protections.

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XTalks

JUNE 29, 2021

Prescription digital medicine company Akili Interactive is set to launch a digital campaign for its FDA-approved video game for the treatment of attention deficit hyperactivity disorder (ADHD). The video game is called EndeavorRx and is the first and only FDA-backed therapy delivered through a video game experience.

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BioSpace

MARCH 28, 2021

The FDA approved ide-cel, which will be marketed under the brand name Abecma.

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pharmaphorum

AUGUST 2, 2021

AstraZeneca has completed the resurrection of its anifrolumab drug for systemic lupus erythematosus (SLE) after claiming FDA approval for the drug as an add-on therapy for adults with the autoimmune disease. The post FDA approves AZ’s anifromulab, ending 10-year lupus drug drought appeared first on.

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XTalks

MAY 17, 2024

The settlement requires Totality to take several specific corrective actions, which include refraining from making any statements that suggest the spa’s products are genuine, FDA-approved Lilly products, and stopping the use of Eli Lilly branding in promoting any of the products.

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pharmaphorum

FEBRUARY 23, 2022

Ben Hargreaves takes a look at why uptake began slowly in both the EU and the US, and then began to accelerate to see biosimilars take a large portion of market share away from originator products. In the US, this led to slow uptake of biosimilars once they were finally approved. The short story so far. Building momentum.

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World of DTC Marketing

MARCH 10, 2022

market until next year, with the pharmaceutical company announcing Tuesday a settlement with the Iceland-based Alvotech. AbbVie, Humira’s manufacturer, kicked off 2020 with a price increase in excess of 7 percent on its mega-blockbuster brand-name treatment. Sales of Humira earned AbbVie $20.7 Sales of Humira earned AbbVie $20.7

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The Pharma Data

MAY 19, 2023

ABBOTT RECEIVES FDA APPROVAL FOR TACTIFLEX™ ABLATION CATHETER FOR TREATMENT OF ABNORMAL HEART RHYTHM Abbott (NYSE: ABT) today announced that the U.S. Unlike other catheters on the market, the TactiFlex catheter uses a tip design with a laser-cut pattern that flexes when in contact with the heart wall. Source link: [link]

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pharmaphorum

APRIL 1, 2022

market is just beginning to heat up. And already in the first quarter of 2022, the FDA approved a third filgrastim biosimilar, Releuko. With 34 approved biosimilars and dozens more in the pipeline, what does this year have in store? Innovator products working to maintain market share.

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The Pharma Data

JANUARY 21, 2021

Cabotegravir is a ViiV product marketed as Cabenuva, and rilpivirine is a Janssen product with a brand name Edurant. Today’s FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care,” said Lynn Baxter, Head of North America, ViiV Healthcare. “Not

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World of DTC Marketing

JUNE 2, 2021

SUMMARY: Doctors said they were dissatisfied were marketing emails (46%), telephone sales calls with sales reps (42%), and both webinars and websites (each at 39%) from pharma companies, according to Indegene. One of our tests, one of the most read emails, had a subject line of “new label information for prescribing just FDA approved.”

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pharmaphorum

AUGUST 17, 2020

The FDA has approved Roche’s satralizumab for the rare autoimmune disorder Neuromyelitis Optica Spectrum Disorder (NMOSD), under the brand name Enspryng. The post Roche takes on Alexion as FDA approves satralizumab in NMOSD appeared first on.

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Pharmaceutical Technology

DECEMBER 14, 2022

Novartis will market these products in the US region during the NDA transfer period of six months and pay the net profits to Harrow. On concluding the NDA transfer period, Harrow will take over the complete US market operations and commence works to manufacture the products through third parties.

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The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. Following today’s FDA approval, the U.S.

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Pharmaceutical Technology

FEBRUARY 10, 2023

On November 22, 2022, the FDA approved CSL Behring’s Hemgenix (etranacogene dezaparvovec), the first gene therapy treatment for hemophilia B, with a staggering manufacturer price of $3.5 Undoubtedly, this has played a factor in the success of market-leading PD-1 inhibitors, Merck & Co.’s

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Pharmaceutical Technology

JUNE 12, 2023

Patients with erectile dysfunction (ED) will now be able to access a topical treatment without the need for a prescription after the US Food and Drug Administration (FDA) greenlit Futura Medical’s Eroxon. The evaporative mode of action leads to smooth muscle relaxation, with the company saying an erection is possible within 10 minutes.

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The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Klisyri is the first FDA approved branded proprietary product for Athenex and will be launched in partnership with Almirall in the U.S. The FDA approval of Klisyri is a significant milestone for Athenex. “The

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The Pharma Data

MARCH 15, 2022

“Today’s approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,” said Sally Choe, Ph.D.,

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World of DTC Marketing

OCTOBER 21, 2021

It focused on four medications, according to the researchers: atezolizumab, which is sold under the brand name Tecentriq; durvalumab, or Drazalex; nivolumab, or Opdivo; and pembrolizumab, or Keytruda. Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5

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pharmaphorum

DECEMBER 14, 2022

For years, Jazz Pharmaceuticals has dominated the market in treating narcolepsy with cataplexy. Sodium oxybate — which in the late 1980s was marketed to bodybuilders and then became known as GHB and criminally used as a date rape drug — has been sold under the brand name Xyrem after gaining FDA approval in 2002.

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The Pharma Data

MARCH 31, 2023

The application to approve Narcan nasal spray for OTC use was granted priority review status and was the subject of an advisory committee meeting in February 2023, where committee members voted unanimously to recommend it be approved for marketing without a prescription.

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The Pharma Data

DECEMBER 17, 2020

There will be a brand-new treatment for actinic keratosis on the market next year, with Tuesday’s FDA approval of Athenix’s Klisyri® (tirbanibulin). This will be the first branded proprietary product for Athenex, which will be launched in the U.S. The FDA approval of Klisyri is a significant milestone for Athenex.

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Delveinsight

FEBRUARY 5, 2021

According to the CDC, in 2018, tobacco companies spent over USD 9 Billion in just promoting and marketing their cigars and cigarettes in the US. Fortunately, there exists FDA-approved therapies and drugs that double the success rates of quitting. Smoking Cessation: What are the drugs available in the market?

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pharmaphorum

JULY 20, 2021

The US regulator had extended its review of the drug by three months – setting back its action date from April to 29 July – but now says that deficiencies in the marketing application “preclude discussion” of labelling and post-marketing requirements. “Despite….advantageous “Despite….advantageous

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World of DTC Marketing

JUNE 6, 2021

The headlines read “FDA approves obesity drug that helped people cut weight 15%” But buyer beware. The drug already exists at a lower dose as an anti-diabetic medication under the brand names Ozempic and Rybelsus made by the same pharmaceutical company, Novo Nordisk.

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pharmaphorum

SEPTEMBER 15, 2022

Mallinckrodt has finally claimed FDA approval for terlipressin as a treatment for hepatorenal syndrome (HRS), after manufacturing problems scuppered an earlier attempt.

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Intouch Solutions

MARCH 31, 2023

For example, about 20 drugs are now FDA-approved to treat multiple myeloma, and these drugs have provided advances in care that have more than tripled the median survival rate in the last two decades. Surprisingly, even brands with compelling study data can struggle. Data alone doesn’t drive behavior.

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XTalks

MAY 2, 2024

In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. Since January, the FDA has already signed off on more than a dozen novel drugs. The agency is reviewing applications for several highly anticipated drugs for approval in 2024.

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Pharmaceutical Technology

JULY 29, 2022

There is no medication specifically approved for ASD-associated agitation and other drugs approved for irritability might be used to manage the agitation episodes, Veenstra-VanderWeele says. Eli Lilly markets olanzapine under the brand name Zyprexa. Nasal spray for acute treatment.

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The Pharma Data

JULY 29, 2021

The substitution may occur at the pharmacy, a practice commonly called “pharmacy-level substitution” – much like how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which vary by state. Biosimilars marketed in the U.S.

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